NCT05362344Active, not recruiting
Colorectal Cancer Screening in Cystic Fibrosis
A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 28 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 21 Mar 2025
- Lead sponsor
- University of Washington, the Collaborative Health Studies Coordinating Center
- Diseases
- Cystic fibrosis, Colorectal cancer
- NCT number
- NCT05362344
What you commit to
- Study type: Observational
- Planned participants: 350
- From 1 Sept 2022 to the primary completion date, 21 Mar 2025
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing
Other illness
- Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study
- Personal history of colon cancer diagnosis and treatment within 5 years of enrollment
Other
- Incapable of understanding the purposes of the study or informed consent for any reason
- Pregnancy
- Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan Medicine - University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Johns Hopkins Hospital, Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| North Carolina Children's Hospital / UNC Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Atrium Health Pulmonary Care Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University Hospitals Rainbow Babies & Children's Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| National Jewish Health, University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Saint Louis University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
Related publications
- A multi-center study of non-invasive colorectal cancer evaluation in cystic fibrosis (NICE-CF).J Cyst Fibros · 2026 · PMID 42248729
This page is information, not medical advice. Discuss any trial with your doctor.