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NCT Number: NCT05163236

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 (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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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),

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • National Cancer Institute, France
  • Registre des Tumeurs Digestives du Finistère

Registry information

Official study title

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

Acronym: FITBACK

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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