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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 4 trial groups
Group A: Higher risk, no neoplasia
Group B: Adenoma
Group C: Colorectal adenocarcinoma
Group D: Average risk, no neoplasia

Trial outcomes

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.

Time frame
At 1 day of biospecimen collection

Secondary outcomes

Other outcomes

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