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| Name | Class |
|---|---|
| Registre des Tumeurs Digestives du Finistère | OTHER |
| National Cancer Institute, France | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRC in excluded population | CRC diagnosed in the population excluded from screening |
| |
| Screen-detected colorectal cancers (SD-CRCs) | CRC diagnosed after a 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 |
| |
| Fecal immunochemical test interval colorectal cancers (FIT IC) | CRCs diagnosed 2 years after a negative FIT |
| |
| colorectal cancers (CRCs) in non-responders | CRCs diagnosed in the FIT non-responders population |
| |
| Post-colonoscopy interval cancers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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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:
Exclusion Criteria:
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This retrospective study evaluated the CRC screening campaign, which took place from January 1, 2016 to December 31, 2017 in the Finistère department.
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| Name | Affiliation | Role |
|---|---|---|
| Michel ROBASZKIEWICZ | University Hospital, Brest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Brest | 29200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17289293 | Background | 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. | |
| 33538338 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2021 | Dec 5, 2021 |
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CRCs diagnosed within 5 years after a colonoscopy performed following a positive test that did not find colorectal cancer |
|
| 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. |
|
| FIT value | 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 | 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 | 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. |
| 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. |
| 25911573 | Background | 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. |
| 26041750 | Background | 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. |
| 23706981 | Background | 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. |
| 23212726 | Background | 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. |
| 24011791 | Background | 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. |
| 24658694 | Background | 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. |
| 20157748 | Background | 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. |
| 25995082 | Background | 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. |
| 28483499 | Background | 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. |
| 32213071 | Background | 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. |
| 28487610 | Background | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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