Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening

Completed

• Conditions: Early Detection of Cancer; Colonoscopy; Mass Screening; Middle Aged; Occult Blood; Colorectal Neoplasms Malignant; Female
• Interventions: Diagnostic Test: Positive fecal immunochemical test (FIT); Diagnostic Test: Fecal immunochemical test (FIT) not performed; Diagnostic Test: Negative fecal immunochemical test (FIT)

• Registration Number: NCT05163236
• Lead Sponsor: University Hospital, Brest

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).

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2021-10-11
• Study Completion: 2021-10-11
• Study First Submitted: 2021-11-18
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-06
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1149

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screen-detected colorectal cancers (SD-CRCs)	Positive fecal immunochemical test (FIT)	CRC diagnosed after a positive fecal immunochemical test (FIT)
CRC in excluded population	Fecal immunochemical test (FIT) not performed	CRC diagnosed in the population excluded from screening
colorectal cancers (CRCs) in non-responders	Fecal immunochemical test (FIT) not performed	CRCs diagnosed in the FIT non-responders population
Colorectal cancers (CRCs) with delayed diagnosis	Positive fecal immunochemical test (FIT)	CRCs diagnosed after a positive fecal immunochemical (FIT) test, but without colonoscopy or \> 2 years after a positive fecal immunochemical test
Fecal immunochemical test interval colorectal cancers (FIT IC)	Negative fecal immunochemical test (FIT)	CRCs diagnosed 2 years after a negative FIT
Post-colonoscopy interval cancers	Positive fecal immunochemical test (FIT)	CRCs diagnosed within 5 years after a colonoscopy performed following a positive test that did not find colorectal cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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),

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Brest, France