About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
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.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University of Michigan Rogel Cancer Center
Lead sponsor
Early Detection Research Network
Collaborator
Clinical Genomics Pathology
Collaborator
VolitionRx
Collaborator
Department of Health and Human Services
Collaborator
Great Lakes New England Clinical Validation Center
Collaborator
National Cancer Institute (NCI)
Collaborator