Thinking of joining a study?

Register your interest

NCT05362344 | Recruiting | Cystic Fibrosis


Colorectal Cancer Screening in Cystic Fibrosis
Sponsor:

University of Washington, the Collaborative Health Studies Coordinating Center

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).

Condition or disease

Cystic Fibrosis

Colorectal Cancer

Adenoma

Intervention/treatment

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
Estimated Enrollment : 350 participants
Official Title : A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : June 30, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Colorectal Cancer Screening in Cystic Fibrosis

Location Details


Please Choose a site



Colorectal Cancer Screening in Cystic Fibrosis

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, California

University of California, Los Angeles

The Angels, California, United States, 90404

Recruiting

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94063

Recruiting

United States, Colorado

National Jewish Health, University of Colorado

Denver, Colorado, United States, 80206

Recruiting

United States, Florida

University of Miami Hospital

Miami, florida, United States, 33136

Recruiting

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Recruiting

United States, Maryland

Johns Hopkins Hospital, Johns Hopkins University

Baltimore, Maryland, United States, 21287

Recruiting

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Recruiting

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Recruiting

United States, road cancer

Michigan Medicine - University of Michigan

Ann Arbor, road cancer, United States, 48109-5212

Recruiting

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Recruiting

United States, Missouri

Saint Louis University

Saint Louis, missouri, United States, 63103

Recruiting

United States, Missouri

Washington University

Saint Louis, missouri, United States, 63110

Recruiting

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Recruiting

United States, North Carolina

North Carolina Children's Hospital / UNC

Chapel Hill, North Carolina, United States, 27514

Recruiting

United States, North Carolina

Atrium Health Pulmonary Care

Charlotte, North Carolina, United States, 28203

Recruiting

United States, Ohio

University Hospitals Rainbow Babies & Children's

Cleveland, Ohio, United States, 44106

Recruiting

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Recruiting

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239-3098

Recruiting

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Recruiting

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15219

Recruiting

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Recruiting

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Active, not recruiting

United States, Texas

University of Texas Southwestern

dallas, Texas, United States, 75390

Recruiting

United States, Utah

University of Utah

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

Recruiting

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Recruiting

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Loading...