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

Recruiting

• Conditions: Adenocarcinoma of the Colon; Stage III Colorectal Cancer; Stage I Colorectal Cancer; Stage II Colorectal Cancer; Adenocarcinoma of the Rectum

• Registration Number: NCT04624555
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2024-12-31
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of mt-sDNA compared to Colonoscopy	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))
Specificity of mt-sDNA compared to Colonoscopy	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))
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).

Trial Locations

Locations (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States