Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000678998
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
5/07/2011
Date last updated
5/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
NSW Cancer Lifestyle and Evaluation of Risk Study (CLEAR Study)
Scientific title
A multi-centre case-control surveillance study in the NSW population to provide ongoing data on the relative importance of known or emerging exposures and their relationships to leading or emerging cancer types.
Secondary ID [1] 262570 0
Nil
Universal Trial Number (UTN)
Trial acronym
CLEAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any primary cancer diagnosed in the past 18 months 268223 0
Condition category
Condition code
Cancer 268354 268354 0 0
Any cancer
Public Health 268362 268362 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Questionnaire (survey) and a blood sample (optional).

Survey questions relate to lifestyle and risk factors a person may have been exposed to during their lifetime. Data from questionnaires of cancer patients and cancer free controls will be compared.

Blood samples will be analysed in the future in a quest to identify known or new biomarkers for disease. Data from blood analyses fror cancer patients and cancer free controls will be compared.

This is a one-off intervention: completion of one questionnaire and donation of one blood sample. There is no follow up for the participant.
Intervention code [1] 266896 0
Not applicable
Comparator / control treatment
Partners of cancer patients are invited to join the study as controls
Control group
Active

Outcomes
Primary outcome [1] 269124 0
Survey questions relate to lifestyle and risk factors a person may have been exposed to during their lifetime.

Data from questionnaires of cancer patients and cancer free controls will be compared.
Timepoint [1] 269124 0
Data is to be supplied within 18 months of cancer diagnosis, but relates to the person's life.
Primary outcome [2] 269131 0
Blood samples will be analysed in the future in a quest to identify known or new biomarkers for disease.

Data from blood analyses fror cancer patients and cancer free controls will be compared.
Timepoint [2] 269131 0
Blood sample is to be supplied within 18 months of cancer diagnosis, and preferably before treatment commences.
Secondary outcome [1] 276981 0
Linkage to routinely collected data (eg NSW Central Cancer Registry, Registry of Births Deaths and Marriages, Admitted Patient Data, ABS, 45 and Up Study, Hereditary Cancer Registry ) will provde further information about the person's health and treatment
Timepoint [1] 276981 0
Linkages are likely to be performed annually, for the entire dataset, during the life of the study. There is no endpoint fixed, at this time.

Eligibility
Key inclusion criteria
Aged 18 years or over; live in NSW; diagnosed with a primary cancer in the past 18 months.
Partners of cancer patients(if there is one) who are cancer free (never had a cancer) are also included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have had a previous cancer are not eligible for the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267369 0
Charities/Societies/Foundations
Name [1] 267369 0
Cancer Council NSW
Country [1] 267369 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council NSW
Address
153 Dowling Street
Woolloomooloo
NSW 2011
Country
Australia
Secondary sponsor category [1] 266434 0
None
Name [1] 266434 0
Address [1] 266434 0
Country [1] 266434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269347 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 269347 0
Ethics Office
Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 269347 0
Australia
Date submitted for ethics approval [1] 269347 0
01/02/2006
Approval date [1] 269347 0
04/09/2006
Ethics approval number [1] 269347 0
H06/081 (changed later, after NEAF, to 07/072)

Summary
Brief summary
The NSW Cancer, Lifestyle, and the Evaluation of Risk (CLEAR) Study is a multi-centre case-control surveillance study in the NSW population. The objectives of the study are:
1. To provide ongoing data on the relative importance of known or emerging exposures and their relationships to leading or emerging cancer types.
2. To investigate in the short term once sample sizes permit, the effects of migration, ethnicity, physical activity, alcohol consumption, smoking, reproductive history, occupation, screening behaviour and certain dietary patterns on the risk of developing cancer of the colon and rectum, prostate, breast and lung, cutaneous melanoma and non-Hodgkin lymphoma.
3. To investigate in the longer term, once sample sizes permit, the effects of these factors on rarer cancer types, such as hepatoma, thyroid, ovarian and pancreatic cancers.
4. To develop a recruitment infrastructure and biological repository of sufficient size to enable the testing of new hypotheses on gene and environment factors, and in some situations, gene-environment interactions, on the risk of cancers affecting the Australian population.
Trial website
www.clearstudy.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32829 0
Address 32829 0
Country 32829 0
Phone 32829 0
Fax 32829 0
Email 32829 0
Contact person for public queries
Name 16076 0
Michael Revius, Project Coordinator
Address 16076 0
Cancer Council NSW
153 Dowling Street
Woolloomooloo
NSW 2011
Country 16076 0
Australia
Phone 16076 0
+61 2 9334 1930
Fax 16076 0
+61 2 8302 3550
Email 16076 0
michaelr@nswcc.org.au
Contact person for scientific queries
Name 7004 0
A Prof Freddy Sitas, Principal Investigator
Address 7004 0
Director, Cancer Research Division
Cancer Council NSW
153 Dowling Street
Woolloomooloo
NSW 2011
Country 7004 0
Australia
Phone 7004 0
+61 2 9334 1837
Fax 7004 0
+61 2 8302 3550
Email 7004 0
freddys@nswcc.org.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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