1200 Participants Needed

Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

Recruiting at 8 trial locations
CA
Overseen ByCancer AnswerLine
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

DE

Dean E Brenner, M.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to sign informed consent
Able to physically tolerate removal of up to 60 ml of blood
Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biospecimen Collection

Collection of stool, blood, serum, plasma, and tissue samples from subjects

1 day
1 visit (in-person)

Biomarker Analysis

Analysis of individual biomarkers and construction of a panel of markers for future screening trials

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after biospecimen collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Colonoscopy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Early Detection Research Network

Collaborator

Trials
4
Recruited
17,500+

Clinical Genomics Pathology

Industry Sponsor

Trials
3
Recruited
1,800+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Great Lakes New England Clinical Validation Center

Collaborator

Trials
1
Recruited
1,200+

VolitionRx

Collaborator

Trials
1
Recruited
1,200+

Department of Health and Human Services

Collaborator

Trials
240
Recruited
944,000+
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