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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
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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Michigan Medicine - University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Johns Hopkins Hospital, Johns Hopkins University
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BaltimoreUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
North Carolina Children's Hospital / UNC
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Atrium Health Pulmonary Care
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CharlotteUnited StatesUnknown status
University Hospitals Rainbow Babies & Children's
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
University of Texas, Southwestern
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DallasUnited StatesUnknown status
National Jewish Health, University of Colorado
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DenverUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
University of Miami Hospital
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MiamiUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Stanford University Medical Center
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Palo AltoUnited StatesUnknown status
Hospital of the University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Saint Louis University
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St LouisUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.