Actively Recruiting
Evaluation of Stool Based Markers for the 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
447 weeks
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
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.
CONDITIONS
Official 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 in colon at stool collection
- Subjects with pathologically confirmed adenoma present in colon at time of stool collection
- Subjects with personal history of adenomas with none present on qualifying colonoscopy
- Subjects with personal history of colorectal cancer more than 3 years ago with none present at qualifying colonoscopy
- Subjects with any family history of colorectal cancer (first degree relative)
- Subjects with current positive screening stool test for blood or DNA within 12 months with no follow-up intervention
- Subjects with no history or current colorectal neoplasia and no family history of colorectal cancer
- Subjects whose screening colonoscopy shows certain types of polyps (e.g., hyperplastic, benign mucosal, polypoid granulation tissue, prolapsed mucosal, inflammatory, transitional mucosal, lipoma, ganglioneuroma, neuroma, hamartomatous polyps)
You will not qualify if you...
- Cancer patients who have had surgery, radiation, or chemotherapy for current colorectal cancer before baseline sample collection
- History of or active inflammatory bowel disease
- Known hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP)
- Inability to provide informed consent
- Other active malignancy within 3 years except specified skin and cervical cancers treated by surgery only
- Patients currently on active chemotherapy or radiation treatment
- Known HIV or chronic active viral hepatitis
- Women who are pregnant
- Patients who have undergone CT colonography (virtual colonoscopy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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