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

NCT05163236 | Completed

• 1 other identifier: FITBACK ( 29BRC21.0147)
• Study Type: observational
• Target: 1,149
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Screening; Fecal immunochemical test; survival; interval cancer

Outcome Measures

Primary Outcomes (1)

• sensitivity of the fecal immunochemical test for the detection of colorectal cancers

  Sensitivity = True positive / True positive + False negative = SD CRCs / SD CRCs + FIT IC

  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 (4)

• 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.

• FIT value

  FIT data included its 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.

• 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.

Study Arms (6)

CRC in excluded population

CRC diagnosed in the population excluded from screening

Diagnostic Test: Fecal immunochemical test (FIT) not performed

Screen-detected colorectal cancers (SD-CRCs)

CRC diagnosed after a positive fecal immunochemical test (FIT)

Diagnostic Test: Positive fecal immunochemical test (FIT)

Colorectal cancers (CRCs) with delayed diagnosis

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

Diagnostic Test: Positive fecal immunochemical test (FIT)

Fecal immunochemical test interval colorectal cancers (FIT IC)

CRCs diagnosed 2 years after a negative FIT

Diagnostic Test: Negative fecal immunochemical test (FIT)

colorectal cancers (CRCs) in non-responders

CRCs diagnosed in the FIT non-responders population

Diagnostic Test: Fecal immunochemical test (FIT) not performed

Post-colonoscopy interval cancers

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

Diagnostic Test: Positive fecal immunochemical test (FIT)

Interventions

Positive fecal immunochemical test (FIT) DIAGNOSTIC_TEST

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.

Colorectal cancers (CRCs) with delayed diagnosis; Post-colonoscopy interval cancers; Screen-detected colorectal cancers (SD-CRCs)

Negative fecal immunochemical test (FIT) DIAGNOSTIC_TEST

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.

Fecal immunochemical test interval colorectal cancers (FIT IC)

Fecal immunochemical test (FIT) not performed DIAGNOSTIC_TEST

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.

CRC in excluded population; colorectal cancers (CRCs) in non-responders

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects who refused to participate in the case of refusal of data collection
• Subject swith CRC other than adenocarcinoma were excluded.

Sponsors & Collaborators

• University Hospital, Brest: lead
• Registre des Tumeurs Digestives du Finistère: collaborator
• Centre Régional de Coordination des Dépistages des Cancers Bretagne (CRCDC Bretagne): collaborator

Study Sites (1)

University Hospital

Brest, 29200, France

Location

Related Publications (13)

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MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Michel ROBASZKIEWICZ

  University Hospital, Brest

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 20, 2021
• Study Start: April 20, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)