University of Washington, the Collaborative Health Studies Coordinating Center
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).
Cystic Fibrosis
Colorectal Cancer
Adenoma
Stool tests
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 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of California, Los Angeles
The Angels, California, United States, 90404
Recruiting
Stanford University Medical Center
Palo Alto, California, United States, 94063
Recruiting
National Jewish Health, University of Colorado
Denver, Colorado, United States, 80206
Recruiting
University of Miami Hospital
Miami, florida, United States, 33136
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Recruiting
Johns Hopkins Hospital, Johns Hopkins University
Baltimore, Maryland, United States, 21287
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Recruiting
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Recruiting
Michigan Medicine - University of Michigan
Ann Arbor, road cancer, United States, 48109-5212
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Recruiting
Saint Louis University
Saint Louis, missouri, United States, 63103
Recruiting
Washington University
Saint Louis, missouri, United States, 63110
Recruiting
Columbia University Medical Center
New York, New York, United States, 10032
Recruiting
North Carolina Children's Hospital / UNC
Chapel Hill, North Carolina, United States, 27514
Recruiting
Atrium Health Pulmonary Care
Charlotte, North Carolina, United States, 28203
Recruiting
University Hospitals Rainbow Babies & Children's
Cleveland, Ohio, United States, 44106
Recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Recruiting
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Active, not recruiting
University of Texas Southwestern
dallas, Texas, United States, 75390
Recruiting
University of Utah
Salt Lake City, Utah, United States, 84132-4701
Recruiting
University of Washington
Seattle, Washington, United States, 98195
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226