Colorectal Cancer Screening in Cystic Fibrosis

NCT05362344 | Active Not Recruiting

• 1 other identifier: NICE-CF
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 26

Brief 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).

Conditions

Colorectal Cancer; Adenoma; Cystic Fibrosis

Keywords

Cystic Fibrosis; Colorectal Cancer; Cancer screening; Adenoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test

  Negative predictive value (NPV) and sensitivity for detection of any adenomas, advanced adenomas, and CRC in stool-based testing.

  3-12 months

Secondary Outcomes (1)

• Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test

  3-12 months

Other Outcomes (8)

• Adenomas

  3-12 months

• Advanced adenomas

  3-12 months

• CRC detection

  3-12 months

Study Arms (1)

NICE-CF Cohort

Adults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer.

Procedure: Stool tests

Interventions

Stool tests PROCEDURE

Non-invasive, stool-based tests for colorectal cancer screening.

Also known as: Stool-based Fecal Immunochemical Testing (FIT) test and Stool-based DNA test (Cologuard) test.

NICE-CF Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cystic Fibrosis Foundation: collaborator
• University of Washington, the Collaborative Health Studies Coordinating Center: lead

Study Sites (26)

University of California, Los Angeles

Los Angeles, California, 90404, United States

Location

Stanford University Medical Center

Palo Alto, California, 94063, United States

Location

National Jewish Health, University of Colorado

Denver, Colorado, 80206, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Hospital, Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109-5212, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

North Carolina Children's Hospital / UNC

Chapel Hill, North Carolina, 27514, United States

Location

Atrium Health Pulmonary Care

Charlotte, North Carolina, 28203, United States

Location

University Hospitals Rainbow Babies & Children's

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

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

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: NONE RETAINED

Stool samples.

MeSH Terms

Conditions

Cystic Fibrosis; Colorectal Neoplasms; Adenoma

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christine Hachem, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Sarah Jane Schwarzenberg, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Steven D. Freedman, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 5, 2022
• Study Start: September 1, 2022
• Primary Completion: March 21, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)