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Colorectal Neoplasms MalignantFITBACKNCT05163236

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

An observational study of Colorectal Neoplasms Malignant and Colonoscopy, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 77 years
What is being tested?
Positive fecal immunochemical test (FIT), Negative fecal immunochemical test (FIT) and Fecal immunochemical test (FIT) not performed
How many people
1,149 participants
Where
1 siteFrance
Study dates
20 Apr 2021to 11 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital

    Brest, 29200

Other trials in France

About this study

Official title: 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.

Read the 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).

Being tested
Positive fecal immunochemical test (FIT), Negative fecal immunochemical test (FIT), Fecal immunochemical test (FIT) not performed
Keywords
Screening, Fecal immunochemical test, survival, interval cancer
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 performedDiagnostic 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.

Study groups in NCT05163236
Study groupRoleWhat they receive
CRC in excluded populationCRC diagnosed in the population excluded from screening
Receives: Diagnostic Test: Fecal immunochemical test (FIT) not performed
Screen-detected colorectal cancers (SD-CRCs)CRC diagnosed after a positive fecal immunochemical test (FIT)
Receives: Diagnostic Test: Positive fecal immunochemical test (FIT)
Colorectal cancers (CRCs) with delayed diagnosisCRCs diagnosed after a positive fecal immunochemical (FIT) test, but without colonoscopy or > 2 years after a positive fecal immunochemical test
Receives: Diagnostic Test: Positive fecal immunochemical test (FIT)
Fecal immunochemical test interval colorectal cancers (FIT IC)CRCs diagnosed 2 years after a negative FIT
Receives: Diagnostic Test: Negative fecal immunochemical test (FIT)
colorectal cancers (CRCs) in non-respondersCRCs diagnosed in the FIT non-responders population
Receives: Diagnostic Test: Fecal immunochemical test (FIT) not performed
Post-colonoscopy interval cancersCRCs diagnosed within 5 years after a colonoscopy performed following a positive test that did not find colorectal cancer
Receives: Diagnostic Test: Positive fecal immunochemical test (FIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Parameters affecting the sensitivity of FIT, risk factors of interval cancer

    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.

    Measured: 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.

  2. FIT value

    FIT value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),

    Measured: FIT data included its value, comprised between 10 and 200 µg haemoglobin/g faeces (analytical limits of quantification),

  3. Survival

    Analysis of survival according to diagnostic circumstances

    Measured: 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.

  4. Treatment

    Analysis of treatment according to diagnostic circumstances

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start20 Apr 2021
  3. Primary completion11 Oct 2021
  4. Study completion11 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163236
Sponsor's protocol ID
FITBACK ( 29BRC21.0147)
Acronym
FITBACK
Status last verified
Dec 2021
First submitted
18 Nov 2021
Last updated
20 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee KJ, Inoue M, Otani T, Iwasaki M, Sasazuki S, Tsugane S; Japan Public Health Center-based Prospective Study. Colorectal cancer screening using fecal occult blood test and subsequent risk of colorectal cancer: a prospective cohort study in Japan. Cancer Detect Prev. 2007;31(1):3-11. doi: 10.1016/j.cdp.2006.11.002. Epub 2007 Feb 7.

    PubMed 17289293

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Drouillard A, Bouvier AM, Rollot F, Faivre J, Jooste V, Lepage C. Conditional net survival: Relevant prognostic information for colorectal cancer survivors. A French population-based study. Dig Liver Dis. 2015 Jul;47(7):597-601. doi: 10.1016/j.dld.2015.03.013. Epub 2015 Mar 27.

    PubMed 25911573

  • Tinmouth J, Lansdorp-Vogelaar I, Allison JE. Faecal immunochemical tests versus guaiac faecal occult blood tests: what clinicians and colorectal cancer screening programme organisers need to know. Gut. 2015 Aug;64(8):1327-37. doi: 10.1136/gutjnl-2014-308074. Epub 2015 Jun 3.

    PubMed 26041750

  • Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.

    PubMed 23706981

  • European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.

    PubMed 23212726

  • Ventura L, Mantellini P, Grazzini G, Castiglione G, Buzzoni C, Rubeca T, Sacchettini C, Paci E, Zappa M. The impact of immunochemical faecal occult blood testing on colorectal cancer incidence. Dig Liver Dis. 2014 Jan;46(1):82-6. doi: 10.1016/j.dld.2013.07.017. Epub 2013 Sep 4.

    PubMed 24011791

  • Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.

    PubMed 24658694

  • Parra-Blanco A, Gimeno-Garcia AZ, Quintero E, Nicolas D, Moreno SG, Jimenez A, Hernandez-Guerra M, Carrillo-Palau M, Eishi Y, Lopez-Bastida J. Diagnostic accuracy of immunochemical versus guaiac faecal occult blood tests for colorectal cancer screening. J Gastroenterol. 2010 Jul;45(7):703-12. doi: 10.1007/s00535-010-0214-8. Epub 2010 Feb 17.

    PubMed 20157748

  • Chiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC, Pan SL, Wu MS, Liao CS, Chen HH, Koong SL, Chiou ST. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015 Sep 15;121(18):3221-9. doi: 10.1002/cncr.29462. Epub 2015 May 20.

    PubMed 25995082

  • van der Vlugt M, Grobbee EJ, Bossuyt PMM, Bos A, Bongers E, Spijker W, Kuipers EJ, Lansdorp-Vogelaar I, Spaander MCW, Dekker E. Interval Colorectal Cancer Incidence Among Subjects Undergoing Multiple Rounds of Fecal Immunochemical Testing. Gastroenterology. 2017 Aug;153(2):439-447.e2. doi: 10.1053/j.gastro.2017.05.004. Epub 2017 May 5.

    PubMed 28483499

  • van de Veerdonk W, Hoeck S, Peeters M, Van Hal G, Francart J, De Brabander I. Occurrence and characteristics of faecal immunochemical screen-detected cancers vs non-screen-detected cancers: Results from a Flemish colorectal cancer screening programme. United European Gastroenterol J. 2020 Mar;8(2):185-194. doi: 10.1177/2050640619882157. Epub 2019 Oct 3.

    PubMed 32213071

  • Portillo I, Arana-Arri E, Idigoras I, Bilbao I, Martinez-Indart L, Bujanda L, Gutierrez-Ibarluzea I. Colorectal and interval cancers of the Colorectal Cancer Screening Program in the Basque Country (Spain). World J Gastroenterol. 2017 Apr 21;23(15):2731-2742. doi: 10.3748/wjg.v23.i15.2731.

    PubMed 28487610

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms Malignant and Colonoscopy, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163236, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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