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NCT Number: NCT04624555

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

The purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.

Recruiting

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Key information

Conditions

Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Stage I Colorectal Cancer Stage II Colorectal Cancer Stage III Colorectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Gregory Cooper, MD

CONTACT

[email protected]

800-641-2422

About this study

Participants who were diagnosed with Stage I-III colorectal cancer will undergo testing with mt-sDNA followed by a questionnaire about satisfaction with mt-sDNA (multitarget stool DNA panel), prior to their scheduled colonoscopies at years 1 and 4 after diagnosis.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity of mt-sDNA compared to Colonoscopy

    Time frame: at 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))

  2. Specificity of mt-sDNA compared to Colonoscopy

    Time frame: at 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))

  3. Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Cooper, MD

CONTACT

[email protected]

1-800-641-2422

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2020
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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