Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02476682




Registration number
NCT02476682
Ethics application status
Date submitted
10/06/2015
Date registered
19/06/2015
Date last updated
27/03/2025

Titles & IDs
Public title
Non-invasive Risk Stratification of CR AMN/SSP
Scientific title
Evaluation of Stool and Blood Based Tests for Colorectal Advanced Mucosal Neoplasia
Secondary ID [1] 0 0
HREC2014/9/4.4(4079)
Universal Trial Number (UTN)
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenomatous Polyps 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - blood or stool samples will be collected

Normal subjects - blood or stool samples will be collected from people referred for screening colonoscopy

Colorectal cancer - blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection

Polyps <10mm and no high risk features - blood or stool samples will be collected from people with no polyps or low risk polyps (\<10mm, no villous component or dysplasia) detected at colonoscopy

Advanced Mucosal Neoplasia - blood or stool samples will be collected from people with AMN detected at resection

Sessile Serrated Adenoma - blood or stool samples will be collected from people with SSP detected at resection

non-colorectal neoplastic disease - Participants with disease that is not colorectal neoplasia. Analysis of this cohort is not a primary endpoint but the investigators will report assay positivity in this group on an opportunistic basis. This cohort will include patients diagnosed with, for example, inflammatory bowel disease or extracolonic cancer.


Other interventions: blood or stool samples will be collected
blood or stool samples will be collected
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demographics
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Level of methylated DNA in circulation
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Level of haemoglobin in stool
Timepoint [3] 0 0
5 years
Primary outcome [4] 0 0
Demographics
Timepoint [4] 0 0
1 day

Eligibility
Key inclusion criteria
* Individuals capable and willing of proving satisfactory informed consent
* Individuals with colonic lesions larger than 20mm
* Individuals diagnosed with laterally spreading or sessile polyp morphology
* Individuals schedules for screening colonoscopy and with no prior history of CRC
* Ability and willingness to collect stool sample at home
* Ability and willingness to undergo venepuncture procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Individuals not able or unwilling to provide informed consent
* Individuals less than 18 year of age
* Individuals who undergo an incomplete colonoscopy or resection, which raises doubt as to the status of the colon (post-hoc exclusion)
* Individuals with a prior history of CRC
* Individuals with a history of Irritable Bowel Disease (IBD), hereditary nonpolyposis colorectal cancer (HNPCC) or Familial adenomatous polyposis (FAP)
* Individuals with bleeding diathesis
* Pregnancy

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS FRACP
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02476682