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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04624555
Other study ID # CASE14219
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Case Comprehensive Cancer Center
Contact Gregory Cooper, MD
Phone 1-800-641-2422
Email gregory.cooper@uhhospitals.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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