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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00843375




Registration number
NCT00843375
Ethics application status
Date submitted
12/02/2009
Date registered
13/02/2009
Date last updated
30/01/2024

Titles & IDs
Public title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Scientific title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Secondary ID [1] 0 0
U01CA086400
Secondary ID [2] 0 0
UMCC 2018.126 GLNE 007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Higher risk, no neoplasia - Negative study colonoscopy and one or more of the following:
Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy
Subjects with a personal history of colorectal cancer (CRC) (longer than 3 years ago because of exclusion criteria of cancer within last 3 years) with none present at time of qualifying colonoscopy
Any family history of CRC (1st degree relative)
Current positive screening stool test for blood, for DNA or for both within 12 months with no follow up intervention

Adenoma - Pathologically confirmed adenomas, both non-advanced adenoma and advanced. Advanced adenoma includes any of the following:
Sessile serrated adenoma
Tubulovillous adenoma
Villous adenoma
Sessile serrated polyp/adenoma
Traditional serrated adenoma
Any adenoma =1 cm

Colorectal adenocarcinoma - Pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy

Average risk, no neoplasia - No neoplasia found at colonoscopy and:
No prior history of adenomas or sessile serrated adenomas
No prior history of CRC
No first degree family history of CRC
Negative colorectal cancer screening test (if performed) for blood, for DNA or for both within 12 months.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biospecimen Retention: Samples with DNA
Timepoint [1] 0 0
At 1 day of biospecimen collection

Eligibility
Key inclusion criteria
- Willing to sign informed consent

- Able to physically tolerate removal of up to 60 ml of blood

- Adults at least 18 years old

- Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)

- Pregnant or nursing women who otherwise meet the eligibility criteria may participate

- Subjects with one of the following:

- Colorectal adenocarcinoma-not treated and in colon at time of stool collection
(CRC bin)

- Adenoma-pathologically confirmed adenoma present in colon at time of stool
collection (Adenoma Bin)

- Higher Risk Non-neoplastic Bin

- Subjects with a personal history of adenomas (confirmed by pathology) with
none present on qualifying colonoscopy

- Subjects with a personal history of CRC (longer than 3 years ago because of
exclusion criteria of cancer within last 3 years) with none present at time
of qualifying colonoscopy

- Any family history of CRC (1st degree relative)

- Current positive screening stool test for blood, for DNA or for both within
12 months with no follow-up intervention.

- Average Risk, Non-neoplastic Bin

- No history or current finding of any colorectal neoplasia including CRC,
adenomas, sessile serrated adenomas and no family history of CRC.

- Subjects who had CRC that was successfully treated at least three years ago
may be considered eligible for the adenoma bin if their polyps are adenomas
and there is no evidence of CRC, or for the higher risk non-neoplastic bin
as noted above.

- Subjects whose screening colonoscopy shows any of these types of polyps may
be included in the non-neoplastic or the higher risk non-neoplastic bin if
they meet the other criteria noted above.

- Hyperplastic polyps

- Benign mucosal polyps

- Polypoid granulation tissue

- Prolapsed mucosal polyps

- Inflammatory polyp

- Transitional mucosal polyp

- Lipoma

- Gangleoneuroma

- Neuroma

- Hamartomatous polyp
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cancer patients who have had any surgery, radiation, or chemotherapy for their current
colorectal cancer prior to collecting the baseline samples

- History of or clinically active Inflammatory Bowel Disease

- Known HNPCC or FAP

- Inability to provide informed consent.

- Other active malignancy within 3 years of enrollment except any of the following:

- Squamous cell carcinoma of the skin

- Basal cell carcinoma of the skin

- Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma
of the cervix treated by surgery only. (Excluded if had pelvic radiation)

- Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery

- Patients on active chemotherapy or radiation treatment for any purpose

- Known HIV or chronic active viral hepatitis

- Women who are pregnant

- CT colonography (virtual colonoscopy) patients

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Michigan Rogel Cancer Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Early Detection Research Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Clinical Genomics Pathology
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
VolitionRx
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Department of Health and Human Services
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Great Lakes New England Clinical Validation Center
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
National Cancer Institute (NCI)
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Colon cancer is the second most common cancer in men and women. It is a disease that can be
prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer
and the polyps that turn into colon cancer. However, due to a variety of factors, including
affordability, time, and age, not all patients are able to be screened. Researchers are
working on other options for early detection that are as accurate as colonoscopy.

The purpose of this study if to determine if stool or blood can be used to detect colon
cancers as early or earlier than colonoscopy. The researchers plan to use these samples to
learn about specific proteins (also known as biomarkers) that may indicate colon polyps,
colon cancer or an increased risk of developing colon cancer. In order to learn more about
preventing and detecting colon and rectal cancer, we are collecting samples from subjects
with cancer, adenomas, and colonoscopies who may be at risk for polyps.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00843375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dean E Brenner, M.D.
Address 0 0
University of Michigan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cancer AnswerLine
Address 0 0
Country 0 0
Phone 0 0
1-800-865-1125
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00843375