Clinical trial · Observational
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study
NCT05163236CI-TRIAL-00055593FITBACKcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonoscopy | — | UNRESOLVED | — |
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Female | — | UNRESOLVED | — |
| Mass Screening | — | UNRESOLVED | — |
| Middle Aged | — | UNRESOLVED | — |
| Occult Blood | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal immunochemical test (FIT) not performed | Diagnostic Test | — | UNRESOLVED |
| Negative fecal immunochemical test (FIT) | Diagnostic Test | — | UNRESOLVED |
| Positive fecal immunochemical test (FIT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- CRC in excluded population
- description
- CRC diagnosed in the population excluded from screening
- interventionNames
- Diagnostic Test: Fecal immunochemical test (FIT) not performed
- label
- Screen-detected colorectal cancers (SD-CRCs)
- description
- CRC diagnosed after a positive fecal immunochemical test (FIT)
- interventionNames
- Diagnostic Test: Positive fecal immunochemical test (FIT)
- label
- 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
- interventionNames
- Diagnostic Test: Positive fecal immunochemical test (FIT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDLee 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. PMID 17289293
- BACKGROUNDSung 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. PMID 33538338
- BACKGROUNDDrouillard 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. PMID 25911573
- BACKGROUNDTinmouth 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. PMID 26041750
- BACKGROUNDBrenner 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. PMID 23706981
- BACKGROUNDEuropean 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.