Testing stool samples for cancer detection in colorectal cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of multitarget stool DNA (mt-sDNA) testing in detecting polyps and cancer in colorectal cancer survivors diagnosed with Stage I-III adenocarcinoma. Participants will provide stool samples for mt-sDNA testing before their scheduled colonoscopies at one and four years post-diagnosis. Following the testing, participants will complete a questionnaire regarding their satisfaction with the mt-sDNA procedure. The study seeks to compare the results of mt-sDNA testing with standard surveillance methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum
* Receipt of preoperative colonoscopy
* Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated

Exclusion Criteria:

* Stage IV colorectal cancer
* Surgical treatment with subtotal colectomy or total proctocolectomy
* Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis
* Presence of advanced adenomas (1 cm or larger, villous features and/or high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen.
* Inability to provide informed consent
* Inability to understand spoken and written English
* Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.

Where it's running

• University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Gregory Cooper, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Gregory Cooper, MD
• Email: gregory.cooper@uhhospitals.org
• Phone: 1-800-641-2422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.