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

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04624555

CASE14219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.