Colorectal Cancer Screening in Cystic Fibrosis (NICE-CF)

A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Adenoma; Cystic Fibrosis
• Intervention / Treatment: Procedure: Stool tests

Detailed Description

NICE-CF is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA test and quantitative FIT test) to standard of care colonoscopy for colorectal cancer (CRC) screening in people with CF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment or remotely.

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90404
      • University of California, Los Angeles
    • Palo Alto, California, United States, 94063
      • Stanford University Medical Center
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health, University of Colorado
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital, Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5212
      • Michigan Medicine - University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
    • St Louis, Missouri, United States, 63103
      • Saint Louis University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • North Carolina Children's Hospital / UNC
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Pulmonary Care
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Rainbow Babies & Children's
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84132-4701
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-invasive, stool-based tests for colorectal cancer screening.; Other Names: Stool-based Fecal Immunochemical Testing (FIT) test and Stool-based DNA test (Cologuard) test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test	Specificity and positive predictive value (PPV) of stool-based testing for any adenomas, advanced adenomas, and CRC	3-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenomas	Overall prevalence of any adenomas detected by screening and by colonoscopy	3-12 months
Advanced adenomas	Overall prevalence of advanced adenomas detected by screening and by colonoscopy	3-12 months
CRC detection	Overall prevalence of CRC detected by screening and by colonoscopy	3-12 months
Sessile serrated lesions	Overall prevalence of sessile serrated lesions detected by screening and by colonoscopy	3-12 months
Stool-based test feasibility	Proportion of patients who complete stool-based testing	3-12 months
Colonoscopy feasibility	Proportion of study participants who complete colonoscopy and stool-based testing	3-12 months
Comparison of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test to detect any adenomas, advanced adenomas, and CRC in PwCF	Comparison of the predictive ability of the two tests	3-12 months
Ease of stool testing	Qualitative surveys on ease of stool sample collection and colonoscopy prep	3-12 months

Collaborators and Investigators

• Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 21, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Colorectal Cancer; Adenoma; Cancer screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colorectal Neoplasms; Adenoma; Cystic Fibrosis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Occult Blood
• Other Study ID Numbers: NICE-CF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No