NCT02567045|Completed
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Sponsor study identifier
interventional
260
1 country
7
Study Start
February 25, 2016
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
March 24, 2020
Actual (reported)This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC). The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2015
Actual (reported)October 2, 2015
Actual (reported)February 25, 2016
Actual (reported)December 31, 2019
Actual (reported)March 24, 2020
Actual (reported)Proportion of patients who participate in each screening arm
2 years
Efficacy measure: QALYs (Quality adjusted life years).
2 years
Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions
2 years
Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces. Colonoscopy will be performed in case of a positive FIT.
One-time Colonoscopy with sedation
FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.
One-time Colonoscopy with sedation.
Federico Sopeña Biarge
Zaragoza, Aragon, 50009, Spain
Cristina Alvarez Urturi, MD
Barcelona, Catalonia, 08003, Spain
Maria Teresa Ocaña Bombardo
Barcelona, Catalonia, 08036, Spain
Inés Castro Novo
Ourense, Galicia, 32005, Spain
Patricia Muñoz Garrrido
San Sebastián, País Vasco, Gipuzcoa, 20080, Spain
Digestive Service, Huc
San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain
María Rodriguez Soler
Alicante, 03010, Spain
Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
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.
Enrique Quintero, MD, PhD
Hospital Universitario de Canarias
260 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2015
First Posted
October 2, 2015
Study Start
February 25, 2016
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect of concomitant behavioral treatment. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):501-510. doi: 10.1097/CHI.0b013e31819c23ed.
Dove-Edwin I, Sasieni P, Adams J, Thomas HJ. Prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: 16 year, prospective, follow-up study. BMJ. 2005 Nov 5;331(7524):1047. doi: 10.1136/bmj.38606.794560.EB. Epub 2005 Oct 21.
Gonzalez-Lopez N, Quintero E, Gimeno-Garcia AZ, Bujanda L, Banales J, Cubiella J, Salve-Bouzo M, Herrero-Rivas JM, Cid-Delgado E, Alvarez-Sanchez V, Ledo-Rodriguez A, de-Castro-Parga ML, Fernandez-Poceiro R, Sanroman-Alvarez L, Santiago-Garcia J, Herreros-de-Tejada A, Ocana-Bombardo T, Balaguer F, Rodriguez-Soler M, Jover R, Ponce M, Alvarez-Urturi C, Bessa X, Roncales MP, Sopena F, Lanas A, Nicolas-Perez D, Adrian-de-Ganzo Z, Carrillo-Palau M, Gonzalez-Davila E; Oncology Group of Asociacion Espanola de Gastroenterologia. Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study). PLoS Med. 2023 Oct 24;20(10):e1004298. doi: 10.1371/journal.pmed.1004298. eCollection 2023 Oct.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
March 24, 2020
Actual (reported)Last Updated
August 10, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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