Active Not RecruitingNot applicableNCT05362344
Official study title

Colorectal Cancer Screening in Cystic Fibrosis

Study 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).

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedStool tests

The study team can explain what participation involves.

Who it may be forCystic Fibrosis · Colorectal Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 24, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Observational

Where is it offered?26 U.S. locations

Locations may change over time.

Who runs it?University of Washington, the Collaborative Health Studies Coordinating Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Washington, the Collaborative Health Studies Coordinating Center
Interventions being studied
Procedure: Stool tests
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Adults with CF ages 18 - 75 years and due for a routine screening or surveillance colonoscopy for colon cancer 2. 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 3. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent 4. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing 5. Able to access the Internet to complete self-administered surveys

Reasons someone may not be able to joinExclusion criteria

1. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study 2. Incapable of understanding the purposes of the study or informed consent for any reason 3. Pregnancy 4. 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. 5. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment 6. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC 7. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California, Los AngelesLos Angeles, California
  • Stanford University Medical CenterPalo Alto, California
  • National Jewish Health, University of ColoradoDenver, Colorado
  • University of Miami HospitalMiami, Florida
  • University of Kansas Medical CenterKansas City, Kansas
  • Johns Hopkins Hospital, Johns Hopkins UniversityBaltimore, Maryland
  • Massachusetts General HospitalBoston, Massachusetts
  • Boston Children's HospitalBoston, Massachusetts
  • Michigan Medicine - University of MichiganAnn Arbor, Michigan
  • University of MinnesotaMinneapolis, Minnesota
  • Saint Louis UniversitySt Louis, Missouri
  • Washington UniversitySt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 24, 2026. Always confirm current availability with the study team.

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