Colonoscopy, Colorectal Neoplasms Malignant, Early Detection of Cancer, Female, Mass Screening, Middle Aged, Occult Blood
Conditions
Keywords
Screening, Fecal immunochemical test, survival, interval cancer
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTPositive fecal immunochemical test (FIT)
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.
DIAGNOSTIC_TESTNegative fecal immunochemical test (FIT)
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.
DIAGNOSTIC_TESTFecal immunochemical test (FIT) not performed
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.
Sponsors
Registre des Tumeurs Digestives du Finistère
Centre Régional de Coordination des Dépistages des Cancers Bretagne (CRCDC Bretagne)
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
* All subjects between 50 and 77 years diagnosed with an in situ or an invasive CRC * Inhabitants of the Finistère area * Subjects were included by period: * from January 2016 to December 2017 for subjects with SD-CRC, non-responders and the excluded population * from January 2016 to December 2019 for subjects with FIT-ICs (2-year interval) * from January 2016 to December 2020 for subjects with post-colonoscopy IC * from January 2018 to December 2020 for subjects with delayed diagnosis
Exclusion criteria
* Subjects who refused to participate in the case of refusal of data collection * Subject swith CRC other than adenocarcinoma were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity of the fecal immunochemical test for the detection of colorectal 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. | Sensitivity = True positive / True positive + False negative = SD CRCs / SD CRCs + FIT IC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameters affecting the sensitivity of FIT, risk factors of interval cancer | 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. |
| FIT value | 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), |
| Survival | 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 |
| Treatment | 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 |
Countries
France
Outcome results
None listed