Open Actively Recruiting

Colorectal Cancer Screening in Cystic Fibrosis


Brief 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).

Study Type


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
75 Years

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
  • Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing

Join this Trial

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Study Stats
Protocol No.
Genetic and Rare Diseases
Deeanna Serna
  • UCLA Westwood
For Providers
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