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Observational Study of mt-sDNA for Colorectal Cancer Surveillance

This study is looking at how well a stool test called mt-sDNA (Cologuard) works to find polyps and cancer in people who have already had colorectal cancer. It compares the results of this stool test to a standard colonoscopy. Researchers also want to know how much patients like using mt-sDNA as a follow-up method. You might be able to join if you've had Stage I, II, or III colon or rectal cancer and had surgery. The study will measure how accurate mt-sDNA is and how acceptable it is to patients at 1 and 4 years after diagnosis. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide a stool sample for mt-sDNA (Cologuard) testing within 90 days before your scheduled colonoscopies at years 1 and 4 after diagnosis. You will also complete a questionnaire about your satisfaction with mt-sDNA.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 years after diagnosis, with assessments at 1 and 4 years.

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NCT04624555

The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors

Recruiting
Not specifiedAges 18+Observational
Case Comprehensive Cancer Center
~50 participants
Updated 2026-04-09 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of mt-sDNA compared to Colonoscopy
Measured over at 1 and 4 years
+2 more outcomes measured

Conditions

Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Stage I Colorectal Cancer
Stage II Colorectal Cancer
Stage III Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Gregory Cooper, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Gregory Cooper, MD
[email protected]
1-800-641-2422
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Sensitivity of mt-sDNA compared to Colonoscopyat 1 and 4 years

    Compare the results between mt-sDNA (categorized as a single positive or negative result) with the findings at colonoscopy, the "gold standard". Colonoscopy will be considered positive if an adenoma or carcinoma is found and otherwise negative. Sensitivity is defined as True Positive (TP)/(TP+ False Negative (FN))

  • Specificity of mt-sDNA compared to Colonoscopyat 1 and 4 years

    Compare the results between mt-sDNA (categorized as a single positive or negative result) with the findings at colonoscopy, the "gold standard". Colonoscopy will be considered positive if an adenoma or carcinoma is found and otherwise negative. Specificity is defined as True Negative (TN)/(TN+ False Positive (FP))

  • Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey.at 1 and 4 years

    Participant acceptance as measured by the Stool Test Satisfaction Survey, which includes 14 questions scored on a Likert scale. Possible scores ranging from 14 - 70, with higher scores indicating better outcomes. Responses will be grouped based on the distribution, but most likely as 1-2 (neutral, unfavorable or least favorable ) versus 3-5 (most favorable or very favorable).