Title of the study is intended for the lay public and should be in easily understood language. It is the title chosen by the researcher(s). Acronyms should not be used in this field. This field will be displayed on the main search page of the WHO search portal.
This is the scientific name of the study provided by the principal investigator or sponsor. This title must be in PICO format including the name of the intervention, the condition being studied, and the primary outcome to be assessed. The registrant does not have to use this title for their publication, ethics application or any other documents.
Other identifying numbers and issuing authorities other than the ANZCTR if any. For example, if the trial has already been registered with another registry, for example, ISRCTN or ClinicalTrials.gov, the secondary ID number and organisation name should be listed. There is no limit on the number of Secondary identifying numbers that can be provided. It is possible that the trial may not have a secondary ID.
Enter only one identifying number and issuing authority in the box (one at a time). Click "Add" to add more boxes if the study has multiple identifying numbers and issuing authorities. There is no limit to the number of Secondary ID entries (boxes) that can be added.
The Universal Trial Number (UTN) is a unique number which aims to facilitate the unambiguous identification of clinical trials registered in Primary Registries in the WHO registry network and displayed on the WHO International Clinical Trials Registry Platform's (ICTRP) Search Portal. A UTN should be obtained early in the history of the trial and should be used every time the trial is identified. To obtain a UTN please go to http://apps.who.int/trialsearch/utn.aspx, and enter in your name, email and organisation. WHO will then send you an email with a link to confirm your request. Once confirmed you will receive a second email from WHO with your UTN details.
If the study has trial acronym, enter in this section. Otherwise, please leave it blank.
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error). If the study is conducted in healthy human volunteers belonging to the target population of the intervention (e.g. preventive or screening interventions), enter the particular health condition(s) or problem(s) being prevented.
Enter only one health condition or problem studied in the box (one condition per box). Click "Add" to add more boxes if the study has multiple health conditions or problems studied. The form allows maximum of 20 entries (boxes) for the health condition(s) or problem(s) studied.
Choose the most appropriate condition category (1st level) and condition code (2nd level) for the study from the list.
Click "Add" to add more boxes if the study has multiple condition categories and condition codes. The form allows maximum of 3 sets of entries for the condition category and condition code.
Describe the specific name of the intervention(s) being studied. Use the International Non-Proprietary Name if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. If the intervention consists of several separate treatments, list them all in one line separated by commas (e.g., "low-fat diet, exercise").
For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc)
For an observational study, this is a description of the condition observed. The duration of the observation must also be described.
Not applicable - Observational study
A study in which no experimental intervention or treatment is applied. The investigator observes the effect of a risk factor, diagnostic test, or treatment on a particular outcome, e.g., the relationship between smoking and heart attacks. It involves observing without altering or influencing that which is being observed. For example, in an observational study, the researchers examine and report on what is happening, without controlling the course of events. Certain outcomes are measured but no attempt is made to affect the outcome (for example, no treatment or no experimental intervention is given).
Diagnosis
A study designed to evaluate one or more interventions aimed at identifying a disease or health condition.
Early detection / screening
A study that involves the systematic examination of a group of participants, in order to separate well persons from those who have an undiagnosed pathologic condition or who are at high risk. It could also refer to the initial evaluation of an individual, intended to determine suitability for a particular treatment modality or to detect specific markers or characteristics that may require further investigation.
Prevention
Study designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.
Treatment: drugs
Study designed to assess the effect(s) of one or more chemical or biological agents including vaccines.
Treatment: surgery
Study designed to assess the effect(s) of one or more manual or operative surgical techniques, whether it be in the fields of cosmetic, elective, experimental, plastic, or replacement surgery. (which are performed to diagnose, treat, or prevent disease or other abnormal conditions).
Treatment: devices
Treatment device studies are designed to evaluate the use of any physical item used in medical treatment whether it be an instrument, piece of equipment, machine, apparatus, appliance, material or other article, and whether it is used alone or in combination with the intention of preventing, diagnosing, treating, and curing a disease or condition. Examples include: artificial limbs, contact lenses, ventilators, catheters, implants, vibration therapy machines.
Treatment: other
The category 'Treatment: other' refers to studies that do not fall under the broad definitions of drug, surgical, or device trials. Examples include interventions such as physiotherapy, chiropractic treatment, cognitive therapy, exercise, special diets, alternative herbal medicines, web-based surveys, motivational classes and interviews, music therapy, stem cell interventions.
Rehabilitation
Rehabilitation studies are designed to evaluate one or more interventions which aim to restore the physical or mental health, function and quality of life in participants who have had or are currently suffering from an illness or injury. Rehabilitation may be performed through physical therapy (e.g. physiotherapy, chiropractic) and/or education (e.g. diet and exercise advice/counselling).
Lifestyle
Studies designed to investigate the effect of interventions which relate to a way of life or style of living. Interventions may aim to alter the attitudes, habits and values of a person or group, and how these participants cope with their physical, psychological, social, and economic environments on a day-to-day basis. Examples include diet and nutrition plans, exercise or physical activity programs, quit smoking programs.
Behaviour
Behavioural studies are designed to assess the effect of interventions which aim to elicit or modify mental or physical actions, responses or conduct in a person or group. Examples of behavioural interventions include cognitive behavioural therapy, exercise behaviour interventions, and breast feeding behavioural interventions.
Other interventions
These studies will comprise of studies that do not fit under any of the above categories and should only be used when no other descriptions adequately describe the purpose of these trials. Examples include interventions using prayer, and singing.
The form allows maximum of 3 entries for the intervention code
Describe the specific name of the comparator/control treatment being studied. The control intervention(s) or comparator(s) is/are the interventions against which the study intervention is evaluated (e.g., placebo, no treatment, active control). If an active control is used, be sure to enter in the name(s) of that intervention, or enter "placebo", "standard treatment" or "no treatment" as applicable.
Describe other details of the comparator/control treatment as applicable (what placebo used or what the standard treatment is, dose, duration, mode of administration, etc).
A "control" group is the type of treatment to which the intervention is being compared. Also known as a "comparator" group. Choose the most appropriate description of the study's control group from the list.
Placebo: an inactive or sham treatment that has no treatment value is given to the subjects, such as sugar pill or saline solution. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
Active: when the control treatment is active. This includes standard care, alternate forms of treatment, no treatment given, or if patients act as their own control (crossover study).
Uncontrolled: when there is no control group, as in single group trials. The same intervention is applied to all subjects in the study.
Historical: a group of people who received their care in the past, i.e., not at the same time as the people receiving the intervention. This selection is not applicable if the trial is a randomised controlled trial.
Dose comparison: the comparator group receives the same treatment as the intervention group, but in a different dose. Dose, duration and mode of administration for both the intervention and control groups need to be described in the intervention field.
Primary outcome(s) is the outcome which provides the primary measure of the effectiveness (or lack of effectiveness) of the intervention. In many studies, more than one variable is used as a primary outcome measure. The Primary Outcome should be the outcome used in sample size calculations, or the main outcome(s) used to determine the effect of the intervention(s).
Provide specific names of all primary outcomes of the trial, one at a time, e.g., "% with Beck depression score > 10" rather than just "depression". Instrument(s) to be used for the assessment/measurement needs to be included/described where possible.
For each outcome, also provide all the timepoints at which it is to be measured.
Enter only one primary outcome in the primary outcome box (one at a time) and the timepoint(s) at which this particular outcome is measured in the timepoint box. Click "Add" to add more boxes if the study has multiple primary outcomes. The form allows maximum of 3 sets of entries for the primary outcome and timepoint.
Examples:
Primary Outcome 1: all cause mortality
Timepoints: at one year after randomisation
Primary Outcome 2: mean Becks depression score
Timepoints: at baseline and at 6, 12, and 18 weeks after intervention commencement
For each primary outcome, also provide all the timepoints at which it is to be measured.
Enter only one primary outcome in the primary outcome box (one at a time) and the timepoint(s) at which this particular outcome is measured in the timepoint box. Click "Add" to add more boxes if the study has multiple primary outcomes. The form allows maximum of 3 sets of entries for the primary outcome and timepoint.
Examples:
Primary Outcome 1: all cause mortality
Timepoints: at one year after randomisation
Primary Outcome 2: mean Becks depression score
Timepoints: at baseline and at 6, 12, and 18 weeks after intervention commencement
Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at timepoints of secondary interest. A secondary outcome may involve the same event, variable, or experience as the primary outcome, but measured at timepoints other than those of primary interest (e.g., Primary outcome: all-cause mortality at 5 years; Secondary outcome: all-cause mortality at 1 year, 3 years), or may involve a different event, variable, or experience altogether (e.g., Primary outcome: all-cause mortality at 5 years; Secondary outcome: hospitalization rate at 5 years).
Provide only specific key secondary outcomes of the trial. Instrument(s) to be used for the assessment/measurement needs to be included/described where possible. For each outcome, also provide all the timepoints at which it is to be measured.
Enter only one secondary outcome in the secondary outcome box (one at a time) and the timepoint(s) at which this particular outcome is measured in the timepoint box. Click "Add" to add more boxes if the study has secondary outcomes. The form allows maximum of 20 sets of entries for the key secondary outcome(s) and timepoint(s).
Examples:
Secondary Outcome 1: cardiovascular mortality
Timepoints: at 6 months after randomisation
Secondary Outcome 2: functional status
Timepoints: at baseline and at 4 and 18 weeks after intervention commencement
For each secondary outcome, also provide all the timepoints at which it is to be measured.
Enter only one secondary outcome in the secondary outcome box (one at a time) and the timepoint(s) at which this particular outcome is measured in the timepoint box. Click "Add" to add more boxes if the study has secondary outcomes. The form allows maximum of 20 sets of entries for the key secondary outcome(s) and timepoint(s).
Examples:
Secondary Outcome 1: cardiovascular mortality
Timepoints: at 6 months after randomisation
Secondary Outcome 2: functional status
Timepoints: at baseline and at 4 and 18 weeks after intervention commencement
Summary of key inclusion criteria of patient characteristics that determine eligibility for participation in the study.
Specify age range of the study's participants.
Enter the numbers for minimum and maximum ages and choose the unit to specify the period (for the age) from the list; Years, Months, Weeks, Days, Hours, No limit, N/A. If there is no age limit for either minimum or maximum age or both, leave the boxes for the number(s) blank and select "No limit" from the list.
Examples:
Minimum Age: 18 Years
Maximum Age: No Limit
Minimum Age: 20 Weeks
Maximum Age: 6 Months
Note: The selection "Not stated" is only for some of the trials previously registered that the registrant did not provide the information when the trial was submitted for registration. It should not be selected for a trial submitted for registration prospectively.
Choose the appropriate description for gender of the study's participants.
Males
Females
Both males and females
Specify whether or not the study includes healthy volunteers.
Summary of key exclusion criteria of patient characteristics that determine eligibility for participation in the study.
Choose the appropriate study type from the list.
Interventional
Observational
Interventional Study - Any research study that prospectively assigns human participants or groups of humans to one or more health-related intervention to evaluate the effect on outcomes. Interventions include, but are not restricted to, drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral approaches, process-of-care changes, preventive care, diagnostic procedures.
Observational Study - A study in which no experimental intervention or treatment is applied. The investigator observes the effect of a risk factor, diagnostic test, or treatment on a particular outcome, e.g., the relationship between smoking and heart attacks. It involves observing without altering or influencing that which is being observed. For example, in an observational study, the researchers examine and report on what is happening, without controlling the course of events. Certain outcomes are measured but no attempt is made to affect the outcome (for example, no treatment or no experimental intervention is given).
If the study is an interventional study, choose the most appropriate purpose of the study from the list.
Treatment: study designed to evaluate one or more interventions for treating a disease, syndrome or other health condition(s).
Prevention: study designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.
Diagnosis: study designed to evaluate one or more interventions aimed at identifying a disease or health condition.
Educational / counselling / training: study designed to assess one or more interventions in an educational, counselling or training environment.
Randomized controlled trial means that allocation of subjects into different groups (i.e., intervention and control) was random or by a method based on chance.
Nonrandomized trial means that allocation of subjects into different groups (i.e., intervention and control) is expressly or deliberately done, and is not random or by chance.
Note: Trials with quasi-randomisation allocation procedures such as allocation by hospital record number, birth date or alternate days of the week, do not qualify as a randomised trial. Therefore, these studies should be classified as nonrandomised trials. These studies are, however, controlled clinical trials (CCTs) and are eligible for registration on the ANZCTR.
If "Allocation to intervention" is randomised controlled trial, describe the method of allocation concealment.
Allocation concealment means that the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed if it was done by, for example:
1. sealed opaque envelopes
2. numbered containers
3. central randomisation by phone /fax /computer
4. allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration
If concealment was not carried out, the text "Allocation is not concealed" should be stated for the data field.
If "Allocation to intervention" is randomised controlled trial, describe the method of sequence generation.
This is the method used to create the random order for the allocation of subjects into different groups. This random order of sequence generation is only relevant if allocation to intervention is "Randomised controlled trial".
Examples of the random order generation include (but are not limited to):
1. Simple randomisation by using a randomisation table from a statistic book
2. Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
3. Simple randomisation by using procedures such as coin-tossing and dice-rolling
4. Permuted block randomisation
5. Stratified allocation. Factors such as centre, age gender or previous treatment are used for the stratification
6. Dynamic (adaptive) random allocation such as Minimisation
If stratified allocation was employed in the study, specify factor(s) used for the stratification.
Quasi-randomisation allocation procedures or inappropriate randomisation methods such as allocation by hospital record number, birth date or alternate days of the week, do not qualify as a random order generation.
Masking / blinding: knowledge of the interventions assigned to subjects. This means the person in question (subjects, therapist, assessor or data analyst) did not know which group the subject had been allocated to. In trials in which key outcomes are self-reported (eg, visual analogue scale, pain diary), the assessor is considered to be blinded if the subject was blinded.
open (masking not used) - all involved in the study know the identity of the intervention assignment. Subject, therapist, assessor and data analyst are not blinded.
blinded (masking used) - when one or more of the parties (subjects, therapist, assessor or data analyst) is/are blinded or unaware of the intervention assignment.
If "blinded (masking used)" option was chosen above, please tick who is/are blinded (choose all that apply), from the list.
the people receiving the treatment/s
the people administering the treatment/s
the people assessing the outcomes
the people analysing the results/data
Choose the most appropriate description of the study's assignment from the list.
Single Group: all participants receive the same intervention throughout the study. Trials in which participants are assigned to receiving one of two or more interventions are not single group studies. Crossover trials are not single group studies.
Parallel: different groups of participants receive different interventions during the same time span of the study.
Crossover: all participants receive all the interventions in different sequences during the study. They act as their own control.
Factorial: participants are randomly allocated to receive either no intervention, one or some interventions, or all interventions simultaneously.
Other: None of the selections from the list provides an appropriate description of the study's assignment. If "Other" is selected for the study's assignment, please give a brief description of the study's assignment in "Other design feature".
Specify other design feature if "Other" is selected for Assignment.
Choose the most appropriate description of the study's endpoint(s) from the list.
Safety: to show if the intervention is safe under conditions of proposed protocol/use
Efficacy: to measure an intervention's influence on a disease or health condition
Safety/efficacy: combination of safety and efficacy
Bio-equivalence: scientific basis for comparing generic and brand name drugs
Bio-availability: rate and extent to which a drug is absorbed or otherwise available to the treatment site in the body
Pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localisation in tissue, biotransformation, and excretion of the compound
Pharmacodynamics: action of drugs in living systems
Pharmacokinetics/Pharmacodynamics: combination of pharmacokinetics and pharmacodynamics
If the study is an observational study, choose the most appropriate purpose of the study from the list.
Natural history: study designed to investigate a disease or condition through observation under natural conditions (i.e., without intervention)
Screening: study designed to assess or examine persons or groups in a systematic way to identify specific markers or characteristics (e.g., for eligibility for further evaluation)
Psychosocial: study designed to observe the psychosocial impact of natural events
If the study is an observational study, choose the most appropriate duration of the study from the list.
Longitudinal: study in which participants are evaluated over long period of time, typically months or years
Cross-sectional: study in which participants are evaluated at one point in time - usually over a short period of time, typically up to 10 weeks
If the study is an observational study, choose the most appropriate sample selection of the study from the list.
Convenient sample: participants or populations are selected at the convenience of the investigator or primarily because they were available at a convenient time or place. The investigators make little or no effort to insure that sample is an accurate representation of some larger group or population
Defined population: participants or populations are selected based on predefined criteria
Random sample: participants or populations are selected by chance in a manner such that all samples of a population have an equal chance of being selected
Case control: participants or populations are selected to match control participants or populations in all relevant factors except for the disease; only the case participants or populations have the disease
If the study is an observational study, choose the most appropriate timing of the study from the list.
Retrospective: study that observes events in the past
Prospective: study that observes events in real time (may also occur in future)
Both: study that combines retrospective and prospective observation
Phases of investigation, usually applied to a drug trial.
Not applicable: this selection is for a non-drug trial
Phase 0: includes exploratory, first-in-human trials. Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was anticipated from preclinical studies. Exploratory trials are conducted before traditional dose escalation and safety studies and gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect.
Phase 1: includes initial study to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. Trials are often dose ranging/escalating trials which are done to determine the maximum dose of a new medication that can be safely given to a patient
Phase 1 / Phase 2: for trials that are at a combined stage of phases 1 and 2
Phase 2: includes controlled clinical studies conducted to evaluate/test the effectiveness of a new drug/medication or intervention for a particular indication or indications in patients with the disease or condition being studied and to determine the common short-term side effects and risks
Phase 2 / Phase 3: for trials that are at a combined stage of phases 2 and 3
Phase 3: includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of a new drug/medication or intervention, including possible adverse reactions. It is also to provide an adequate basis for physician labelling
Phase 3 /Phase 4: for trials that are at a combined stage of phases 3 and 4
Phase 4: post-marketing study to delineate additional information. Trials are done to monitor the toxicity, risks, utility, benefits and optimal use after the efficacy of the drug/medication or intervention has been proven
Estimated enrolment date (dd/mm/yyyy) of the first participant. This could be actual trial start date if the trial is registered after commencement.
The total number of subjects the investigators plan to enrol before closing the trial to new participants.
Note : This is a "number only" field (e.g. 25)
1. Not yet recruiting: participants are not yet being recruited or enrolled
2. Open to recruitment: participants are currently being recruited and enrolled
3. Temporary halt or suspended: there is a temporary halt in recruitment and enrolment but potentially will resume
4. Terminated: recruiting or enrolling participants has halted and will not resume
5. Closed to recruitment of participants: follow-up continuing - closed to recruitment of participants and follow-up is still continuing
6. Closed to recruitment of participants: follow-up complete - closed to recruitment of participants and follow-up is complete
7. Completed - closed to recruitment of participants and data analysis complete
Note: Items 3 & 4 will only be available for when the information of all registered trials on the ANZCTR is updated.
Major source(s) of monetary or material or infrastructure support for the trial (e.g., funding agency, foundation, company, hospital, university, etc.). This refers to the name of the organisation(s) that provided funding for the study.
Funding type: choose the most appropriate type of the study's funding source from the list.
Name of funding source: enter only one name of the study's funding source (one at a time).
Address of funding source: enter the address of the study's funding source listed in the "Name" section.
Country of funding source: choose the country of the study's funding source listed in the "Name" section from the list.
Click "Add" tro add more boxes if the study has multiple funding sources. The form allows maximum of 20 sets of entries for the funding source(s).
The individual, organisation, group or other legal person taking on the responsibility for securing the arrangements to initiate and/or manage a study, including arrangements to ensure that the design of the study meets appropriate standards and to ensure appropriate conduct and reporting. The primary sponsor is normally the main applicant or principle investigator for regulatory authorisation or funding to begin the study. The primary sponsor is responsible for ensuring that the trial is properly registered. It may or may not be the main funder.
Primary sponsor type: choose the most appropriate type of the study's primary sponsor from the list.
Name of primary sponsor: enter only one name of the study's primary sponsor.
Address of primary sponsor: enter the address of the study's primary sponsor listed in the "Name" section.
Country of primary sponsor: choose the country of the study's primary sponsor listed in the "Name" section from the list.
The form allows only one entry for primary sponsor. For additional sponsors, please refer to the secondary sponsor(s) section.
Additional individuals, organisations or other legal persons, if any, that have agreed with the primary sponsor to jointly take on responsibilities of sponsorship. A secondary sponsor may have agreed to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group and/or to act as the sponsor's legal representative in relation to some or all of the trial sites. A secondary sponsor may take responsibility for the accuracy of trial registration information submitted.
Secondary sponsor type: choose the most appropriate type of the study's secondary sponsor from the list.
Name of secondary sponsor: enter only one name of the study's secondary sponsor (one at a time).
Address of secondary sponsor: enter the address of the study's secondary sponsor listed in the "Name" section.
Country of secondary sponsor: choose the country of the study's secondary sponsor listed in the "Name" section from the list.
Click "Add" tro add more boxes if the study has multiple secondary sponsors. The form allows maximum of 20 sets of entries for the secondary sponsor(s).
Additional individuals, organisations or other legal persons, if any, that have agreed with the primary sponsor to jointly take on responsibilities of sponsorship. A collaborator may have agreed to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group and/or to act as the sponsor's legal representative in relation to some or all of the trial sites.
Collaborator type: choose the most appropriate type of the study's collaborator from the list.
Name of collaborator: enter only one name of the study's collaborator (one at a time).
Address of collaborator: enter the address of the study's collaborator listed in the "Name" section.
Country of collaborator: choose the country of the study's collaborator listed in the "Name" section from the list.
Click "Add" tro add more boxes if the study has multiple collaborators. The form allows maximum of 20 sets of entries for the other collaborator(s).
Choose the appropriate answer from the list.
If Yes has been selected, please provide the following information:
Name of ethics committee: enter only one name of the ethics committee (one at a time).
Address of ethics committee: enter the address of the ethics committee listed in the "Name" section.
Country of ethics committee: choose the country of the ethics committee listed in the "Name" section from the list.
Date of approval: enter the date when the ethics approval has been obtained.
HREC Number: enter HREC identification number (Human Research Ethics Committee Identification Number). This number is assigned to the ethics application either at the time of submission or granting approval.
Click "Add" to add more boxes if the study has received ethics approval from multiple ethics committees. The form allows maximum of 50 sets of entries for the ethics committees.
If No has been selected, it is mandatory to provide the date when the ethics application was submitted or the date which the trial's primary sponsor or their representatives intend to submit an ethics application in Date submitted/Date which intend to submit to ethics committee section.
If Yes has been selected for ethics approval, please provide the name, address and country of ethics committee.
If Yes has been selected for ethics approval, please provide the date of ethics approval.
If No has been selected for ethics approval, it is mandatory to provide the date when the ethics application was submitted or the date which the trial's primary sponsor or their representatives intend to submit an ethics application.
If Yes has been selected for ethics approval, please provide the HREC identification number (Human Research Ethics Committee Identification Number). This number is assigned to the ethics application either at the time of submission or granting approval.
Choose the appropriate answer from the list to specify if the recruitment site(s) is within or outside Australia. Please tick both boxes if the recruitment sites are within and outside Australia.
If Australia has been selected for countries of recruitment, please specify the postcode(s) of the area(s) where the participants is/will be recruited for the study. Click "Add" to add more boxes for the postcodes if the study has multiple recruitment sites. The form allows maximum of 50 entries for the postcodes.
If Outside Australia has been selected for countries of recruitment, it is mandatory to list all country(s) that the participants is/will be recruited for the study by choosing the country's name from the list. Please also specify the state/province within each particular country. Click "Add" to add more boxes for the countries and their state/province if the study has multiple recruitment sites. The form allows maximum of 50 sets of entries for the countries of recruitment and their state/province.
Short description of the primary purpose of the study, including a brief statement of the study hypothesis, intended for the lay public.
If the study has a trial website, enter the web address / URL (Uniform Resource Locator) in this section. Otherwise, please leave it blank.
If the study has a list of presentations/publications, enter these details in this section. Otherwise, please leave it blank.
Name, address, telephone number, fax number and email address of the contact person who will respond to general queries, including information about current recruitment status. Only professional contact details should be provided.
Name, address, telephone number, fax number, email address and affiliation of the person to contact for scientific inquiries about the trial (e.g., principal investigator, medical director for the study at the sponsor). For a multi-centre study, enter the contact information for the lead Principal Investigator or overall medical director. Only professional contact details should be provided.
Name, address, telephone number, fax number, email address and affiliation of the person to contact for updating the trial information after the trial has been registered with the ANZCTR. Only professional contact details should be provided.
If the contact person responsible for updating information is the same person as the contact person for public queries OR contact person for scientific queries, please leave this section blank.
Early or Local: The cancer is located in the organ in which it started or it has spread to local lymph nodes. It has not spread to distant sites. For example, early breast cancer or Dukes B and Dukes C colorectal cancer.
Locally advanced: The cancer may be larger in size and may have spread to local lymph nodes. For example, locally advanced pancreatic cancer or locally advanced lung cancer.
Locally recurrent: The cancer has recurred at the same site of the primary cancer. For example, locally recurrent breast cancer or locally recurrent rectal cancer.
Metastatic/Widespread: The cancer has spread to other organs distant from the site the cancer started. For example, breast cancer that has metastasized to bone, lung or liver.
Not applicable: The clinical trial is a prevention trial or other trial where cancer stage is not relevant.
Treatment: Hormones: Treatment with endocrine therapy may include tamoxifen or aromastase inhibitors for the treatment of breast cancer or goserelin for the treatment of prostate cancer.
Treatment: Chemotherapy: Treatment with oral or injected medications used to kill cancer cells.
Treatment: Targeted therapies and biological therapies: Targeted therapies block the growth of cancer cells by interfering with specifc targeted molecules needed for tumour growth. Examples include monoclonal antibodies such as trastuzumab (Herceptin), bevacizumab (Avastin) and cetuximab (Erbitux) and small molecule inhibitors such as lapatinib (Tykerb), imatinib (Glivec)and sunitinib (Sutent).
Biological therapies use the body's immune system, either directly or indirectly, to fight cancer or to lessen the side effects that may be caused by some cancer treatments. Examples include interferons, interleukins, colony-stimulating factors, vaccines, gene therapies and nonspecific immunomodulating agents.
Treatment: Radiotherapy: The use of ionizing radiation to treat cancer.
Treatment: Surgery: Any operation that requires surgical removal of cancer.
Treatment: Other: Other treatment types or drug classifications that are not listed in the treatment options above.
Antiemetics: Trials investigating the outcomes from the use of antiemetics.
Complementary: Complementary therapies complement conventional medical treatment. Complementary medicines can include herbal, vitamin, mineral, homoeopathic, nutritional and other supplements. Therapies include herbal medicine, Chinese medicine, chiropractic, naturopathy, osteopathy, acupuncture, homoeopathy, reflexology, aromatherapy, Alexander technique, Bach and other flower remedies, massage, hypnotherapy, shiatsu, ayurvedic medicine, nutritional medicine, yoga, anthroposophical medicine, spiritual healing, iridology, kinesiology, meditation and others.
Palliative care: Interventions used to control symptoms and improve quality of life.
Prevention/Screening: A test or treatment used to prevent cancer from developing or from progressing to cause symptoms or death. This might include a screening test, for example mammograms to prevent death from breast cancer.
Psychosocial: Interventions or techniques that involve counseling, training, communication or educational based programs.
Lifestyle: Trials investigating the outcomes from lifestyle changes. Lifestyle changes include exercise (physiotherapy, aerobic interval training, weight training) and diet (any dietary intervention).
Rehabilitation: An intervention to restore or improve physical abilities lost from cancer.
Please list the known and possible side effects for all treatment arms. This field needs to be written in the format:
Control arm: List side effects (from most common to least common)
(Space)
Intervention arm 1: List side effects (from most common to least common)
(Space)
Intervention arm 2: List side effects (from most common to least common)
(Space)
Etc for each arm of the trial.
If the trial is single arm, please include the side effects in the following format:
Intervention arm: List side effects (from most common to least common)
If side effects are not applicable for this trial, please include the text 'Nil Known' in this field.
This question is designed to give participants a general idea about the potential financial cost of participating in the trial.
This question is designed to give participants a general idea about the potential time involved for participating in the trial.
This question is designed to give participants a general idea about the potential travel commitments for participating in the trial.
Select the Australian state(s) where the participants are being recruited.
This date refers to when the trial has/anticipates/will stop recruiting patients into the trial.