Spots Global Cancer Trial Database for Colorectal Cancer Screening in Cystic Fibrosis
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Trial Identification
Brief Title: Colorectal Cancer Screening in Cystic Fibrosis
Official Title: A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
Study ID: NCT05362344
Interventions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Los Angeles, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
National Jewish Health, University of Colorado, Denver, Colorado, United States
University of Miami Hospital, Miami, Florida, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Johns Hopkins Hospital, Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Boston Children's Hospital, Boston, Massachusetts, United States
Michigan Medicine - University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Saint Louis University, Saint Louis, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Columbia University Medical Center, New York, New York, United States
North Carolina Children's Hospital / UNC, Chapel Hill, North 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
Oregon Health & Science University, Portland, Oregon, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern, Dallas, Texas, United States
University of Utah, Salt Lake City, Utah, United States
University of Washington, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Christine Hachem, MD
Affiliation: St. Louis University
Role: PRINCIPAL_INVESTIGATOR
Name: Sarah Jane Schwarzenberg, MD
Affiliation: University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
Name: Steven D. Freedman, MD, PhD
Affiliation: Beth Israel Deaconess Medical Center
Role: PRINCIPAL_INVESTIGATOR
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