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Trial registered on ANZCTR


Registration number
ACTRN12621000976886
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
26/07/2021
Date last updated
1/07/2022
Date data sharing statement initially provided
26/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tissue and Blood-based Biomarker in Colorectal Cancer
Scientific title
Investigating potential tissue and blood-based biomarkers from participants with various bowel pathologies, for the early detection of colorectal cancer in adults .
Secondary ID [1] 303787 0
Protocol 2011.225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 321286 0
Benign bowel disease 321287 0
Condition category
Condition code
Cancer 319073 319073 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Collection and analysis of tissue and blood samples from patients diagnosed with colorectal cancer, benign bowel disease and healthy volunteers (no bowel pathology) for the purpose of investigating the potential use of novel non-invasive biomarkers for screening, detection of recurrence, predicting clinical outcome and response to therapies.
Participants may be asked to give serial blood samples for the purposes of monitoring biomarker changes over time. These samples will be taken at the same time as routine clinical assessments to avoid inconvenience to the participant. The schedule for blood collections will therefore differ depending on which pathology the participant has, and which biomarker is being investigated. All such information will be supplied to the participant at the time of consent.
Any tissue samples to be used will be retrospectively sourced from pathology laboratories, using tissue that was taken for clinical care outside of this project. All tissue supplied will be de-identified before testing by research laboratories.
Follow up data will be collected from hospital records from a participants clinical visit. All participants, regardless of pathology, will be followed up for a total of five years from first consent. Retrospective data relative to the project may be collected from a participants medical record after consent has been signed.
Intervention code [1] 320101 0
Early Detection / Screening
Comparator / control treatment
Biomarkers will be compared between participants with colorectal cancer and those with other bowel pathologies, such as polyps or Irritable Bowel Syndrome, and those who are healthy volunteers. Comparison between these three groups may allow biomarker signatures to become apparent leading to further investigation.
Control group
Active

Outcomes
Primary outcome [1] 326978 0
Exploratory outcome looking at circulating tumour DNA changes using blood samples.
Timepoint [1] 326978 0
At time of diagnosis, recurrence, and in follow up after surgery.
Primary outcome [2] 326979 0
Disease response to systemic chemotherapy and/or biologic agents determined by CT imaging
Timepoint [2] 326979 0
At time of diagnosis, recurrence, and in follow up after surgery.
Primary outcome [3] 328309 0
Correlating DNA polymorphisms with protein/cytokine biomarkers
Timepoint [3] 328309 0
serial bloods (e.g. at 3, 6 or 18 months) after surgery and at recurrence.
Secondary outcome [1] 393331 0
Exploratory assessment of blood-based biomarkers in patients with a primary diagnosis of colorectal cancer
Timepoint [1] 393331 0
Blood samples will be taken at enrolment, and then every 3, 6 or 12 months post-enrolment until disease recurrence is noted

Eligibility
Key inclusion criteria
1. Male and female
2. At least 18 years of age
3. Patients with histologically confirmed colorectal cancer, benign bowel disease or normal volunteers (no bowel pathology)
4. Provision of written informed consent where blood collection is required
5. Able to be accessible for follow up and data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
2. Patients who are not accessible for follow-up.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/07/2013
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2034
Actual
Sample size
Target
1000
Accrual to date
834
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 19028 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 19036 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 19037 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 19038 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 19039 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [6] 19040 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [7] 19041 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment postcode(s) [1] 33583 0
3011 - Footscray
Recruitment postcode(s) [2] 33584 0
3021 - St Albans
Recruitment postcode(s) [3] 33575 0
3050 - Parkville
Recruitment postcode(s) [4] 33585 0
3128 - Box Hill
Recruitment postcode(s) [5] 33586 0
3220 - Geelong
Recruitment postcode(s) [6] 33588 0
3280 - Warrnambool
Recruitment postcode(s) [7] 33587 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 308190 0
Other
Name [1] 308190 0
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Country [1] 308190 0
Australia
Primary sponsor type
Other
Name
The Walter and Eliza Hall Institute of Medical Research (WEHI)
Address
1G Royal Parade
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 309013 0
None
Name [1] 309013 0
Address [1] 309013 0
Country [1] 309013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308173 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 308173 0
The Royal Melbourne Hospital
Level 2
South West
300 Grattan Street
Parkville Victoria 3052
Ethics committee country [1] 308173 0
Australia
Date submitted for ethics approval [1] 308173 0
26/11/2011
Approval date [1] 308173 0
06/06/2012
Ethics approval number [1] 308173 0

Summary
Brief summary
This study is investigating whether known (already identified) or new potential biomarkers found in blood or tissue can be used to detect colorectal cancer, or to predict the outcomes of patients who have been diagnosed with colorectal cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have confirmed colorectal cancer or benign (non-cancerous) bowel disease or you are healthy without any history of bowel disease (cancerous or benign)

Study details
All participants who choose to enroll in this study will be asked to provide up to 6 blood samples over a 5 year period. Participants who have confirmed colorectal cancer will be asked to allow research on tissue collected at surgery or colonoscopy for 5 years post consent. Participants who have confirmed cancer will also be asked to share their medical history and any new test results with the research team to determine how the disease is responding to treatments provided.

It is hoped this research will identify new biomarkers that may be used to improve health outcomes for colorectal cancer patients, either by allowing earlier detection of cancer, or by allowing detection of people who have a genetic risk of cancer so that they might take steps to reduce their future risk of developing cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109798 0
A/Prof Jeanne Tie
Address 109798 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 109798 0
Australia
Phone 109798 0
+61 3 9345 2707
Fax 109798 0
Email 109798 0
tie.j@wehi.edu.au
Contact person for public queries
Name 109799 0
Mr Matthew Chapman
Address 109799 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 109799 0
Australia
Phone 109799 0
+61 3 9345 2828
Fax 109799 0
Email 109799 0
matthew.chapman@mh.org.au
Contact person for scientific queries
Name 109800 0
Mr Matthew Chapman
Address 109800 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
Country 109800 0
Australia
Phone 109800 0
+61 3 9345 2828
Fax 109800 0
Email 109800 0
matthew.chapman@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.