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

Recruiting now

Conditions studied: Colonic Neoplasms

In brief

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.

Key facts

Study ID

NCT00843375

Run by

University of Michigan Rogel Cancer Center

People needed

1200

Starts

2019-08-07

Expected to finish

2028-03-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subjects with a personal history of 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.
• 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

You may not qualify if…

• Cancer patients who have had any surgery, radiation, or chemotherapy for their current colorectal cancer prior to collecting the baseline samples
• History of or clinically active Inflammatory Bowel Disease
• Known HNPCC or FAP
• Inability to provide informed consent.
• Other active malignancy within 3 years of enrollment except any of the following:
• Squamous cell carcinoma of the skin
• Basal cell carcinoma of the skin
• Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
• Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
• Patients on active chemotherapy or radiation treatment for any purpose
• Known HIV or chronic active viral hepatitis
• Women who are pregnant
• CT colonography (virtual colonoscopy) patients

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Flinders Medical Center — Adelaide, South Australia, Australia (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada
• Carle Cancer Center — Urbana, Illinois, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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