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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adenocarcinoma of the Rectum; Adenocarcinoma of the Colon; Stage III Colorectal Cancer; Stage I Colorectal Cancer; Stage II Colorectal Cancer

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gregory Cooper, MD; Phone Number: 1-800-641-2422; Email: gregory.cooper@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
      • Contact: Gregory Cooper, MD; Phone Number: 800-641-2422; Email: CTUReferral@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who are diagnosed with stage I-III colorectal cancer. All participants who are within 1 year of colon cancer resection will be asked to participate in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of mt-sDNA compared to Colonoscopy	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))	at 1 and 4 years
Specificity of mt-sDNA compared to Colonoscopy	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))	at 1 and 4 years
Participant acceptance of mt-sDNA as a follow up strategy compared to colonoscopy as measured by the Stool Test Satisfaction Survey.	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).	at 1 and 4 years

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Gregory Cooper, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenocarcinoma
• Other Study ID Numbers: CASE14219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No