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Colonoscopy versus Stool-based Testing for Older Adults with a History of Colon Polyps: The COOP Trial

Primary Investigator
Menees, Stacy
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05612347
UM Number
2024.043
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Cancer Control and Prevention
ID (Protocol)
53756
Secondary Protocol No
HUM00252179
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Colon
Rectum
Summary
This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Eligibility: Inclusion Criteria
  •   * English or Spanish speaking
  •   * Personal history of colorectal polyps
  •   * Most recent colonoscopy with =2 non-advanced polyps
  •   * Currently due or coming due within 12 months for colonoscopy
  •   * Able to provide written informed consent
Exclusion Criteria
  •   * Personal history of colorectal cancer
  •   * Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)
  •   * Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn''s disease)
  •   * Most recent colonoscopy with advanced polyp(s) or >=3 non-advanced polyps
  •   * Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)
  •   * Patients unable to provide written informed consent