Clinical trial NCT05362344: Colorectal Cancer Screening in Cystic Fibrosis
Official title: A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cystic Fibrosis
Colorectal Cancer
Adenoma
Keywords: Cystic Fibrosis
Colorectal Cancer
Cancer screening
Adenoma
Lead sponsor: University of Washington, the Collaborative Health Studies Coordinating Center
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2022-05-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18-75 with cystic fibrosis (CF) eligible for routine colon cancer screening

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
timeFrame: 3-12 months
Secondary outcomes:
measure: Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
timeFrame: 3-12 months
Other outcomes:
measure: Adenomas
timeFrame: 3-12 months
measure: Advanced adenomas
timeFrame: 3-12 months
measure: CRC detection
timeFrame: 3-12 months
measure: Sessile serrated lesions
timeFrame: 3-12 months
measure: Stool-based test feasibility
timeFrame: 3-12 months
measure: Colonoscopy feasibility
timeFrame: 3-12 months
measure: Comparison of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test to detect any adenomas, advanced adenomas, and CRC in PwCF
timeFrame: 3-12 months
measure: Ease of stool testing
timeFrame: 3-12 months
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Health, University of Colorado
state: Colorado
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Children's Hospital / UNC
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Pulmonary Care
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Rainbow Babies & Children's
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: St. Louis University
name: Christine Hachem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Sarah Jane Schwarzenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Steven D. Freedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: