Clinical trial NCT05163236: Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening
Official title: Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms Malignant
Colonoscopy
Early Detection of Cancer
Female
Mass Screening
Middle Aged
Occult Blood
Keywords: Screening
Fecal immunochemical test
survival
interval cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Registre des Tumeurs Digestives du Finistère
name: Centre Régional de Coordination des Dépistages des Cancers Bretagne (CRCDC Bretagne)
First posted: 2021-12-20
Enrollment: 1149
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study evaluated the CRC screening campaign, which took place from January 1, 2016 to December 31, 2017 in the Finistère department.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: sensitivity of the fecal immunochemical test for the detection of colorectal cancers
timeFrame: 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.
Secondary outcomes:
measure: Parameters affecting the sensitivity of FIT, risk factors of interval cancer
timeFrame: 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.
measure: FIT value
timeFrame: FIT data included its value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),
measure: Survival
timeFrame: 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.
measure: Treatment
timeFrame: 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.
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Brest
name: Michel ROBASZKIEWICZ
role: STUDY_DIRECTOR
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