An observational study in Colonic Neoplasms, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Michigan Rogel Cancer Center · Observational
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.
In recognition of the fact that novel potential biomarkers are continually being identified and will need to be validated in a rapid, efficient and scientifically rigorous manner, the NCI has made an enormous commitment to the development of a network that will facilitate biomarker development and validation in multiple organ sites. As part of the National Cancer Institute-funded Early Detection Research Network (EDRN), the Great Lakes-New England Clinical Epidemiological Center (GLNE CEC) proposes a research study that validates potential molecular markers ("biomarkers") for the detection of precancerous and cancerous conditions and cancer risk assessment. Although examples of such biomarkers are currently in clinical use (i.e. CEA, CA-125), there are limitations to all of them. Our consortium focuses on gastrointestinal neoplasia. The goals of this phase of the proposed research are:
Construction of a panel of markers from those considered in Objective 1 to discriminate, under a number of assumptions concerning prevalence and cost of misclassification, between:
To build our collection, we propose to collect stool, FIT, serum, plasma, and tissue samples from 1200 new subjects. Each biomarker will be analyzed individually and considered as a potential panel marker to be used for future largescale screening longitudinal trials. (This protocol previously recruited an additional 682 subjects from January 2006 to June 2010.)
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 280 across 349 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Subjects with one of the following:
Higher Risk Non-neoplastic Bin
Average Risk, Non-neoplastic Bin
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.
Exclusion Criteria:
Other active malignancy within 3 years of enrollment except any of the following:
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
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
Pathologically confirmed colorectal cancer either present at time of stool collection or discovered during colonoscopy
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.
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.
Time frame: At 1 day of biospecimen collection
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University of Michigan Rogel Cancer Center