Colorectal Cancer Screening in Cystic Fibrosis

About

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

Observational

Eligibility

Gender

All

Healthy Volunteers

No

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