Colorectal Cancer Screening in Cystic Fibrosis (NCT05362344) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Colorectal Cancer Screening in Cystic Fibrosis
United States350 participantsStarted 2022-09-01
Plain-language summary
This multi-center study will compare multi-target DNA and quantitative FIT stool-based testing to colonoscopy in individuals with Cystic Fibrosis (CF) undergoing colon cancer screening with colonoscopy. The primary endpoint is detection of any adenomas, including advanced adenomas and colorectal cancer (CRC).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adults with CF ages 18 - 75 years and due for a routine screening or surveillance colonoscopy for colon cancer
✓. Cystic Fibrosis diagnosis, defined by a sweat chloride test result ≥ 60 mmol/L (may be of historic value), and/or documented CF-causing CFTR mutations and clinical features of CF
✓. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent
✓. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing
✓. Able to access the Internet to complete self-administered surveys
Exclusion criteria
✕. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study
✕. Incapable of understanding the purposes of the study or informed consent for any reason
✕. Pregnancy
✕. Active inflammatory bowel disease as defined by a prior diagnosis of Crohn's Disease or Ulcerative Colitis, based on both clinical and histopathologic findings and the individual currently on medical therapy for Crohn's disease or Ulcerative Colitis.
✕. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment
✕. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC
What they're measuring
1
Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
Timeframe: 3-12 months
Trial details
NCT IDNCT05362344
SponsorUniversity of Washington, the Collaborative Health Studies Coordinating Center