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| Name | Class |
|---|---|
| Fundacion Cientifica de la Asociacion Española contra el Cancer | UNKNOWN |
| Instituto de Salud Carlos III | OTHER_GOV |
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Aims:
Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).
Study groups:
Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal occult blood testing | Active Comparator | Fecal immunochemical testing biennially |
|
| Colonoscopy | Active Comparator | Colonoscopy one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunochemical fecal occult blood test | Procedure | Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal cancer-related mortality | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate | 2 years | |
| Complication rate | 10 years | |
| Colorectal cancer incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Castells, MD | Hospital Clínic, Barcelona, Spain | Principal Investigator |
| Enrique Quintero, MD | Hospital Universitario de Canarias, Tenerife, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Spain | ||||
| Hospital Clínico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42272346 | Derived | Cubiella J, Garcia-Benito C, Castells A, Quintero E, Bujanda L, Castan-Cameo S, Diaz-Tasende J, Lanas A, Ono A, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Regueiro-Exposito C, Davila-Pinon P, Diez-Martin A; COLONPREV study investigators. Long-Term Colorectal Cancer Incidence After Adenoma and Serrated Polyp Removal: Results From the Colonprev Trial. United European Gastroenterol J. 2026 Jun;14(5):e70245. doi: 10.1002/ueg2.70245. | |
| 42270316 |
| Label | URL |
|---|---|
| Webpage of the Spanish Gastroenterological Association, which endorses COLONPREV trial | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2024 |
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| Colonoscopy | Procedure | Every 10 years, with sedation. |
|
| 15 years |
| Adherence rate | 10 years |
| Advanced colorectal neoplasm detection rate | 2 years |
| Madrid |
| Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Spain |
| Hospital Meixoeiro | Ourense | Spain |
| Hospital de Donosti | San Sebastián | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| Comunidad Valencia | Valencia | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | Spain |
| Derived |
| Castells A, Quintero E, Chen H, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M; COLONPREV Study Investigators. Colonoscopy versus biennial FIT screening: a post hoc sustained-strategy analysis of the COLONPREV Trial. Gut. 2026 Jun 10:gutjnl-2026-338896. doi: 10.1136/gutjnl-2026-338896. Online ahead of print. |
| 41715250 | Derived | Castells A, Quintero E, Serra-Burriel M, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Coll-Vinent B, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D; COLONPREV study investigators. Sex- and Age-Stratified Outcomes of Colonoscopy Versus Faecal Immunochemical Testing: Post-Analysis of the COLONPREV Study. United European Gastroenterol J. 2026 Mar;14(2):e70169. doi: 10.1002/ueg2.70169. |
| 40158525 | Derived | Castells A, Quintero E, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazan R, Alonso-Abreu I, Banales JM, Hernandez V, Portillo I, Vanaclocha-Espi M, de la Vega M; COLONPREV study investigators. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025 Apr 12;405(10486):1231-1239. doi: 10.1016/S0140-6736(25)00145-X. Epub 2025 Mar 27. |
| 33657038 | Derived | Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122. |
| 24859111 | Derived | Salas D, Vanaclocha M, Ibanez J, Molina-Barcelo A, Hernandez V, Cubiella J, Zubizarreta R, Andreu M, Hernandez C, Perez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentin V, Lanas A, Quintero E, Castells A. Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening. Cancer Causes Control. 2014 Aug;25(8):985-97. doi: 10.1007/s10552-014-0398-y. Epub 2014 May 24. |
| 24681078 | Derived | Castells A, Quintero E, Alvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernandez C, Jover R, Hijona E, Portillo I, Enriquez-Navascues JM, Hernandez V, Martinez-Turnes A, Menendez-Villalva C, Gonzalez-Mao C, Sala T, Ponce M, Andres M, Teruel G, Peris A, Sopena F, Gonzalez-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo A, Pellise M, Balaguer F, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrandiz J, Gonzalez-Hernandez MJ, Andreu M, Bessa X; COLONPREV Study Investigators. Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests. Clin Gastroenterol Hepatol. 2014 Oct;12(10):1708-16.e4. doi: 10.1016/j.cgh.2014.03.022. Epub 2014 Mar 27. |
| 24574776 | Derived | Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038. |
| 23751980 | Derived | Bujanda L, Lanas A, Quintero E, Castells A, Sarasqueta C, Cubiella J, Hernandez V, Morillas JD, Perez-Fernandez T, Salas D, Andreu M, Carballo F, Bessa X, Cosme A, Jover R; COLONPREV Study Investigators. Effect of aspirin and antiplatelet drugs on the outcome of the fecal immunochemical test. Mayo Clin Proc. 2013 Jul;88(7):683-9. doi: 10.1016/j.mayocp.2013.04.016. Epub 2013 Jun 7. |
| 22356323 | Derived | Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895. |
| Mar 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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