Colorectal Cancer Screening in Cystic Fibrosis

Running, not enrolling

Conditions studied: Cystic Fibrosis, Colorectal Cancer, Adenoma

In brief

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).

Key facts

Study ID

NCT05362344

Run by

University of Washington, the Collaborative Health Studies Coordinating Center

People needed

350

Starts

2022-09-01

Expected to finish

2026-06-30

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• National Jewish Health, University of Colorado — Denver, Colorado, United States
• University of Miami Hospital — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Hospital, Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Michigan Medicine - University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• North Carolina Children's Hospital / UNC — Chapel Hill, North Carolina, United States
• Atrium Health Pulmonary Care — Charlotte, North Carolina, United States
• University Hospitals Rainbow Babies & Children's — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.