Actively Recruiting
The Utility and Feasibility of Multitarget Stool DNA as a Surveillance Procedure in Colorectal Cancer Survivors
Led by Case Comprehensive Cancer Center · Updated on 2026-04-09
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether testing stool for a panel of markers using multitarget stool DNA (mt-sDNA) can detect polyps and colorectal cancer as effectively as standard colonoscopy in survivors of Stage I-III colorectal cancer. This observational study aims to compare mt-sDNA testing to colonoscopy at 1 and 4 years after diagnosis, assessing both detection accuracy and participant satisfaction with mt-sDNA as a follow-up method. Participants diagnosed with Stage I to III colorectal cancer will provide a stool sample for mt-sDNA testing within 90 days before their scheduled colonoscopies at years 1 and 4 post-diagnosis. The mt-sDNA kits (Cologuard) will be distributed by study personnel and mailed directly to the testing laboratory. This study does not involve any experimental treatments but focuses on the feasibility and utility of mt-sDNA as a surveillance procedure. During the study, participants will complete a questionnaire about their satisfaction with the mt-sDNA test after providing stool samples and undergoing colonoscopies. Researchers will measure the sensitivity and specificity of mt-sDNA compared to colonoscopy at both time points and evaluate participant acceptance of mt-sDNA for follow-up surveillance. The study will continue until September 2026, and participant involvement includes stool sample collection, questionnaires, and standard colonoscopies as part of their routine care.
CONDITIONS
Brief Title
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - At years 1 and 4 after diagnosis
Participants provide stool samples for multitarget stool DNA testing and complete satisfaction questionnaires before their scheduled colonoscopies as part of routine surveillance.
2 visits corresponding to scheduled colonoscopies at year 1 and year 4
Trial Site Locations
Total: 1 location
1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
G
Gregory Cooper, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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