Actively Recruiting
Evaluation of Stool-Based Markers for Early Detection of Colorectal Cancers and Adenomas
Led by University of Michigan Rogel Cancer Center · Updated on 2026-05-11
1200
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
E
Early Detection Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying colon cancer, which is the second most common cancer in men and women, focusing on early detection methods that may prevent the disease. This research evaluates whether stool or blood samples can detect colon cancers as early or earlier than colonoscopy by analyzing specific proteins called biomarkers. The study collects samples from people with colon cancer, adenomas, and those at risk to better understand and improve detection and prevention of colon and rectal cancer. The study collects stool, fecal immunochemical test (FIT), serum, plasma, and tissue samples from about 1200 participants, including those with colorectal cancer, adenomas, higher risk without neoplasia, and average risk without neoplasia. These samples will be analyzed individually and combined to develop panels of markers to distinguish between healthy individuals and those with various stages of colon polyps or cancer. This research is part of a network funded by the National Cancer Institute to validate biomarkers for gastrointestinal cancers and improve screening tools. Participants will provide stool and blood samples and undergo colonoscopy results review. Researchers will collect data on the presence of DNA in biospecimens and compare new markers to the current standard FIT test. The study includes those with and without colorectal neoplasia and tracks clinical and tissue samples linked to patient data. Participant involvement may include sample collection, clinical assessments, and follow-up, with the total study duration varying by individual. The study aims to improve early detection methods through detailed biomarker research and sample banking.
CONDITIONS
Brief Title
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 eligibility may participate
- Subjects with colorectal adenocarcinoma not treated and present at stool collection
- Subjects with pathologically confirmed adenomas present at stool collection
- Subjects at higher risk with personal history of adenomas or colorectal cancer over 3 years ago, family history of colorectal cancer, or recent positive stool screening test without follow-up
- Subjects at average risk with no history or current colorectal neoplasia and no family history of colorectal cancer
You will not qualify if you...
- Cancer patients who had surgery, radiation, or chemotherapy for current colorectal cancer before baseline samples
- History of or active Inflammatory Bowel Disease
- Known hereditary colon cancer syndromes (HNPCC or FAP)
- Inability to provide informed consent
- Other active malignancies within 3 years except certain skin and cervical cancers treated by surgery only
- Patients on active chemotherapy or radiation for any reason
- Known HIV or chronic active viral hepatitis
- Women who are pregnant
- Patients undergoing CT colonography (virtual colonoscopy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint
Participants provide stool, blood, and other biological samples to evaluate biomarkers related to colorectal cancer risk and presence.
1 visit (in-person)
Duration - Up to the study completion in March 2028
Participants' samples and data are used to support ongoing biomarker validation and future research related to colorectal cancer detection.
No additional visits required
Trial Site Locations
Total: 13 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Carle Cancer Center
Urbana, Illinois, United States, 61801
Completed
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Completed
8
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
9
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Completed
10
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
12
Flinders Medical Center
Adelaide, South Australia, Australia, 5001
Actively Recruiting
13
St. Michael's Hospital
Toronto, Ontario, Canada
Withdrawn
Research Team
C
Cancer AnswerLine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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