Status:
ACTIVE_NOT_RECRUITING
Colorectal Cancer Screening in Cystic Fibrosis
Lead Sponsor:
University of Washington, the Collaborative Health Studies Coordinating Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Colorectal Cancer
Eligibility:
All Genders
18-75 years
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 colonoscop...
Detailed Description
NICE-CF is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA test and quantitative FIT test) to standard of care colonoscopy for colorectal cancer (CRC) screening i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05362344
Start Date
September 1 2022
End Date
June 30 2026
Last Update
May 4 2025
Active Locations (26)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90404
2
Stanford University Medical Center
Palo Alto, California, United States, 94063
3
National Jewish Health, University of Colorado
Denver, Colorado, United States, 80206
4
University of Miami Hospital
Miami, Florida, United States, 33136