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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Middle Aged; Early Detection of Cancer; Female; Colorectal Neoplasms Malignant; Occult Blood; Colonoscopy; Mass Screening

Treatments: Diagnostic Test: Positive fecal immunochemical test (FIT); Diagnostic Test: Negative fecal immunochemical test (FIT); Diagnostic Test: Fecal immunochemical test (FIT) not performed

Study type: Observational

Funder types: Other

Identifiers

NCT05163236

FITBACK ( 29BRC21.0147)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,149 patients

Sex: All

Ages: 50 to 77 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,149 participants in 6 patient groups

CRC in excluded population

Description:

CRC diagnosed in the population excluded from screening

Treatment:

Diagnostic Test: Fecal immunochemical test (FIT) not performed

Screen-detected colorectal cancers (SD-CRCs)

Description:

CRC diagnosed after a positive fecal immunochemical test (FIT)

Treatment:

Diagnostic Test: Positive fecal immunochemical test (FIT)

Colorectal cancers (CRCs) with delayed diagnosis

Description:

CRCs diagnosed after a positive fecal immunochemical (FIT) test, but without colonoscopy or \> 2 years after a positive fecal immunochemical test

Treatment:

Diagnostic Test: Positive fecal immunochemical test (FIT)

Fecal immunochemical test interval colorectal cancers (FIT IC)

Description:

CRCs diagnosed 2 years after a negative FIT

Treatment:

Diagnostic Test: Negative fecal immunochemical test (FIT)

colorectal cancers (CRCs) in non-responders

Description:

CRCs diagnosed in the FIT non-responders population

Treatment:

Diagnostic Test: Fecal immunochemical test (FIT) not performed

Post-colonoscopy interval cancers

Description:

CRCs diagnosed within 5 years after a colonoscopy performed following a positive test that did not find colorectal cancer

Treatment:

Diagnostic Test: Positive fecal immunochemical test (FIT)