University Hospital
Brest, 29200, France
NCT Number: NCT05163236
Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.
Looking for future studies?
Notify Me50 year–77 year
All sexes
Observational
Brest, 29200, France
Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic accuracy for CRCs than previous screening tests. Determining the incidence of post-test interval CRCs, diagnosed after a negative FIT and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. The primary objective of this study was to evaluate the performance of FIT during the CRC screening campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (IC).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Time frame: We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Sensitivity = True positive / True positive + False negative = SD CRCs / SD CRCs + FIT IC
Time frame: We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Age, sex, stages, localizations, comparison by Chi2 or Fisher's test for categorical data and Student's test for quantitative data. Multivariate analysis using logistic regression.
Time frame: FIT data included its value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),
FIT value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),
Time frame: We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Analysis of survival according to diagnostic circumstances
Time frame: We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Analysis of treatment according to diagnostic circumstances
University Hospital, Brest
Other
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study
Acronym: FITBACK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03775980
Colonic Diseases, Colonic Neoplasms
Zagreb, Croatia
View Trial DetailsNCT06314971
Colonic Diseases, Colonic Neoplasms
Duarte, California, United States
View Trial DetailsNCT04744688
Abdominal Neoplasms, Bleeding
Aarhus, Aarhus N, Denmark
View Trial DetailsNCT06410729
Colonic Diseases, Colonic Neoplasms
View Trial Details