Colorectal Cancer Screening in Cystic Fibrosis

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.