Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
350 participants
OBSERVATIONAL
2022-09-01
2026-06-30
Brief Summary
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Detailed Description
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The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool samples and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between submitting stool samples and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, participating sites must notify the DCC to obtain preapproval for greater than 3 months duration between stool-based testing and colonoscopy.
CF patients who are eligible for CRC screening will either be enrolled during an in-person CF clinic visit or via phone/video if clinic visits are taking place remotely. Participants will be asked to perform stool sample collection at home, and then complete their colonoscopy within three to twelve months of submission of the stool sample.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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NICE-CF Cohort
Adults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer.
Stool tests
Non-invasive, stool-based tests for colorectal cancer screening.
Interventions
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Stool tests
Non-invasive, stool-based tests for colorectal cancer screening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
University of Washington, the Collaborative Health Studies Coordinating Center
OTHER
Responsible Party
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Principal Investigators
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Christine Hachem, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Sarah Jane Schwarzenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Steven D. Freedman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
National Jewish Health, University of Colorado
Denver, Colorado, United States
University of Miami Hospital
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins Hospital, Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
North Carolina Children's Hospital / UNC
Chapel Hill, North Carolina, United States
Atrium Health Pulmonary Care
Charlotte, North Carolina, United States
University Hospitals Rainbow Babies & Children's
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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NICE-CF
Identifier Type: -
Identifier Source: org_study_id
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