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Could a simple stool test replace colonoscopy for cancer screening in cystic fibrosis?

NCT ID NCT05362344

Diagnosis Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether stool-based tests (like the FIT test and Cologuard) can accurately detect colorectal cancer and precancerous polyps in adults with cystic fibrosis. Researchers will compare these non-invasive tests to the standard colonoscopy in 350 participants. The goal is to find a simpler, less invasive screening option for this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stool-based tests (FIT and DNA test)
What this could lead to
If successful, this could provide a non-invasive, easier screening option for colorectal cancer in people with cystic fibrosis.
What could go wrong
This is an observational study, not a treatment trial. Stool tests may miss some cancers or polyps, and colonoscopy remains the gold standard.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults 18-75 with cystic fibrosis (CF) eligible for routine colon cancer screening

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion 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

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Conditions

The condition(s) this trial relates to.

adenoma colorectal cancer colorectal neoplasm cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenoma Colorectal cancer Cystic fibrosis

Contacts and locations

Locations

  • Atrium Health Pulmonary Care

    Charlotte, North Carolina, 28203, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Johns Hopkins Hospital, Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48109-5212, United States

  • National Jewish Health, University of Colorado

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • North Carolina Children's Hospital / UNC

    Chapel Hill, North Carolina, 27514, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098, United States

  • Saint Louis University

    St Louis, Missouri, 63103, United States

  • Stanford University Medical Center

    Palo Alto, California, 94063, United States

  • University Hospitals Rainbow Babies & Children's

    Cleveland, Ohio, 44106, United States

  • University of California, Los Angeles

    Los Angeles, California, 90404, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Miami Hospital

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84132-4701, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

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