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NCT04624555 | RECRUITING | Adenocarcinoma of the Colon

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

Condition or disease

Adenocarcinoma of the Colon

Adenocarcinoma of the Rectum

Stage I Colorectal Cancer

Stage II Colorectal Cancer

Stage III 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
Estimated Enrollment : 50 participants
Official Title : The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors
Actual Study Start Date : 2022-10-31
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors

Location Details

NCT04624555

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How to Participate

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Locations

RECRUITING

United States, Ohio

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106