Colorectal Cancer Screening in Cystic Fibrosis

Colorectal Cancer Clinical Trial

— NICE-CF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362344
• Other study ID #: NICE-CF
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Washington, the Collaborative Health Studies Coordinating Center
• Contact: Freda Branch
• Phone: 314-678-5468
• Email: freda.branch[@]health.slu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• Stool tests
Non-invasive, stool-based tests for colorectal cancer screening.

Locations

Country	Name	City	State
United States	Michigan Medicine - University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital, Johns Hopkins University	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	North Carolina Children's Hospital / UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South 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	University of Texas Southwestern	Dallas	Texas
United States	National Jewish Health, University of Colorado	Denver	Colorado
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami Hospital	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington, the Collaborative Health Studies Coordinating Center	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adenomas	Overall prevalence of any adenomas detected by screening and by colonoscopy	3-12 months
Other	Advanced adenomas	Overall prevalence of advanced adenomas detected by screening and by colonoscopy	3-12 months
Other	CRC detection	Overall prevalence of CRC detected by screening and by colonoscopy	3-12 months
Other	Sessile serrated lesions	Overall prevalence of sessile serrated lesions detected by screening and by colonoscopy	3-12 months
Other	Stool-based test feasibility	Proportion of patients who complete stool-based testing	3-12 months
Other	Colonoscopy feasibility	Proportion of study participants who complete colonoscopy and stool-based testing	3-12 months
Other	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
Other	Ease of stool testing	Qualitative surveys on ease of stool sample collection and colonoscopy prep	3-12 months
Primary	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	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