COLONiC FITness
Research type
Research Study
Full title
Faecal immunochemical testing to detect advanced adenomas and colorectal carcinoma in people with cystic fibrosis
IRAS ID
296774
Contact name
Aoife Lillis
Contact email
Sponsor organisation
Guys and St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
296774, IRAS Project Number
Duration of Study in the UK
0 years, 8 months, 28 days
Research summary
Summary of Research
The risk of colorectal cancer (CRC) in people with cystic fibrosis (pwCF) is purported to be 5-10 times greater compared with the general population and 25-30 times greater in pwCF who have had organ transplantation.
Screening guidelines from the Cystic Fibrosis Foundation (CFF) recommend bowel screening from 40 years of age and above, or 30 years and above in those who have had an organ transplant. They recommend that screening is done with colonoscopy and a more intensive bowel regimen is used in pwCF.
Faecal immunochemical testing (FIT) of stool samples is a standard first line investigation in the non-CF population. The accuracy of FIT is unknown in CF and thus the aim of our research is to assess its accuracy by comparing it to the gold standard of colonoscopy.Summary of Results
Objectives
With better survival in CF the prevalence of extra-pulmonary complications is increasing. The risk of colorectal cancer (CRC) is purported to be 5-10 times greater than the general population. Our aim was to start a bowel screening programme at our adult CF centre (n=567) in those aged ≥40 years (pre-transplant) and assess the accuracy of faecal immunochemical testing (FIT) to determine its use as an alternative to colonoscopy.
Methods
All those clinically stable, ≥40 years (without contraindications), were invited for bowel screening colonoscopy (Cystic Fibrosis Foundation Guidelines 2018) including CF-specific bowel preparation. Concomitant stool samples were collected for FIT. Questionnaires were completed to assess acceptability of the process. The accuracy of FIT was compared to colonoscopy.
Results
N=89 (64% eligible) had colonoscopy; n=72 (81%) completed FIT. Median (range) age 48.1 (40.2-83.6) yrs, n=31 (35%) female, FEV1median 67% (28-131). No CRC was found. N=31 (35%) had polyps; n=6 (7%) were advanced adenomas. Median (range) FIT score 5 (5-161) μg/g, of which n=2 were above the current national cut-off of 120 μg/g. N=1 had an advanced adenoma and the other is awaiting CT colonography as complete colonoscopy was not tolerated. The remaining n=5 with advanced adenoma had a FIT <20 μg/g. 98.7% 'agreed' or 'strongly agreed' FIT was acceptable, 86.4% 'agreed' or 'strongly agreed' that they would have further colonoscopy if clinically indicated.
Conclusion
From our large adult cohort (pre-transplant) we did not find CRC so the accuracy of FIT could not be determined. Importantly we found a lower prevalence of advanced adenomas than reported in the literature (~25%, Niccum 2016), this requires further investigation. Although FIT was acceptable and is the modality of choice in general population screening, larger multi-centre studies are required to determine its accuracy in CF.REC name
Wales REC 3
REC reference
21/WA/0148
Date of REC Opinion
30 Apr 2021
REC opinion
Favourable Opinion