Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
7 other identifiers
observational
1,200
3 countries
13
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedStudy Start
First participant enrolled
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 8, 2025
May 1, 2025
8.6 years
February 12, 2009
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Biospecimen Retention: Samples with DNA
Blood samples, up to 60 mls, will be obtained according to standard operating procedures. Subjects will collect stool samples per the schedule in the study calendar. Collection of Frozen Normal and Adenoma or Cancer Tissue: For individuals with large adenomas who are undergoing endoscopic resection, the fresh surgical sample will be obtained by the endoscopist.
At 1 day of biospecimen collection
Study Arms (4)
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.
Eligibility Criteria
Patients diagnosed with colorectal cancer and adenomas and scheduled for surgical or endoscopic resection or subjects scheduled for a colonoscopy will be recruited from collaborating consortium centers.
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michigan Rogel Cancer Centerlead
- Early Detection Research Networkcollaborator
- Clinical Genomics Pathologycollaborator
- VolitionRxcollaborator
- Department of Health and Human Servicescollaborator
- Great Lakes New England Clinical Validation Centercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (13)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
NYU Langone Health
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
Flinders Medical Center
Adelaide, South Australia, 5001, Australia
St. Michael's Hospital
Toronto, Ontario, Canada
Biospecimen
Blood samples, up to 60 mls, will be obtained according to standard operating procedures. Subjects will collect stool samples per the schedule in the study calendar. Collection of Frozen Normal and Adenoma or Cancer Tissue: For individuals with large adenomas who are undergoing endoscopic resection, the fresh surgical sample will be obtained by the endoscopist.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dean E Brenner, M.D.
University of Michigan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
August 7, 2019
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
May 8, 2025
Record last verified: 2025-05