The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
NCT ID: NCT04624555
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-10-31
2026-01-30
Brief Summary
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Detailed Description
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Participants will be asked to provide a stool sample for mt-sDNA (Cologuard) testing that will be collected within 90 days before their scheduled colonoscopy. The kit will be given to the participant by study personnel and mailed back directly to Exact Science.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Receipt of preoperative colonoscopy
* Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gregory Cooper, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Locations
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University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Gregory Cooper, MD
Role: primary
Other Identifiers
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CASE14219
Identifier Type: -
Identifier Source: org_study_id