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

December 6, 2021 updated by: University Hospital, Brest

Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRC in excluded population
CRC diagnosed in the population excluded from screening
Diagnostic test: Fecal 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.
Screen-detected colorectal cancers (SD-CRCs)
CRC diagnosed after a positive fecal immunochemical test (FIT)
Diagnostic test: Positive 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.
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)
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)
CRCs diagnosed 2 years after a negative FIT
Diagnostic test: Negative 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.
colorectal cancers (CRCs) in non-responders
CRCs diagnosed in the FIT non-responders population
Diagnostic test: Fecal 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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity of the fecal immunochemical test for the detection of colorectal cancers
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters affecting the sensitivity of FIT, risk factors of interval cancer
Time Frame: 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.
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
Time Frame: 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),
FIT data included its value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),
Survival
Time Frame: 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
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
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Registre des Tumeurs Digestives du Finistère
Centre Régional de Coordination des Dépistages des Cancers Bretagne (CRCDC Bretagne)

Investigators

  • Study Director: Michel ROBASZKIEWICZ, University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

October 11, 2021

Study Completion (Actual)

October 11, 2021

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FITBACK ( 29BRC21.0147)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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