Testing stool samples for cancer detection in colorectal cancer survivors
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
This study is testing if a new stool test can help find polyps and cancer in colorectal cancer survivors to see if it works better than regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04624555 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Stage I, II, or III adenocarcinoma of the colon or rectum who have undergone preoperative colonoscopy and bowel resection.
Not a fit: Patients with Stage IV colorectal cancer or those with certain conditions such as inflammatory bowel disease or polyposis syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of colorectal cancer recurrence and polyps, improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar stool DNA testing approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.