Using stool and blood tests to detect colorectal cancer early

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

This study is testing if stool and blood tests can help find colorectal cancer and polyps earlier than regular colonoscopies for people at risk.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Michigan Rogel Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT00843375 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of stool and blood biomarkers in detecting colorectal cancers and adenomas earlier than traditional colonoscopy. Researchers will collect samples from participants with confirmed colorectal cancer, adenomas, and those at risk for polyps to identify specific proteins that may indicate the presence of these conditions. The study is part of a larger initiative by the National Cancer Institute to develop and validate novel biomarkers for early cancer detection. By assessing the utility of these biomarkers, the study seeks to improve screening methods for colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of colorectal adenomas, colorectal cancer, or those at higher risk due to family history.

Not a fit: Patients who have had colorectal cancer treatment within the last three years or do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more accessible method for early detection of colorectal cancer, potentially saving lives.

How similar studies have performed: Other studies have shown promise in using biomarkers for cancer detection, but this specific approach is part of ongoing efforts to validate new methods.

Eligibility criteria

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
      * Lipoma
      * Gangleoneuroma
      * Neuroma
      * 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 this trial is running

Los Angeles, California and 12 other locations

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

Study contacts

• Principal investigator: Dean E Brenner, M.D. — University of Michigan
• Study coordinator: Cancer AnswerLine

Conditions Colonic Neoplasms