NCT00843375 · University of Michigan Rogel Cancer Center
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
What this study is about
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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Gangleoneuroma
- Hamartomatous polyp Exclusion Criteria:
- 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
- Los Angeles, California
- Urbana, Illinois
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- New York, New York
- Chapel Hill, North Carolina
- Portland, Oregon
- Hershey, Pennsylvania
- Houston, Texas
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations