Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

• ClinicalTrials.gov Identifier: NCT00906997
• Recruitment Status: Unknown
• First Posted: May 21, 2009
• Last Update Posted: April 1, 2015
• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association; Fundacion Cientifica de la Asociacion Española contra el Cancer; Instituto de Salud Carlos III
• Information provided by (Responsible Party): Antoni Castells, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: May 19, 2009
• First Posted Date: May 21, 2009
• Last Update Posted Date: April 1, 2015
• Study Start Date: November 2008
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 19, 2009): Colorectal cancer-related mortality [ Time Frame: 10 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 19, 2009)

• Compliance rate [ Time Frame: 2 years ]
• Complication rate [ Time Frame: 10 years ]
• Colorectal cancer incidence [ Time Frame: 15 years ]
• Adherence rate [ Time Frame: 10 years ]
• Advanced colorectal neoplasm detection rate [ Time Frame: 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
• Official Title: Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Brief Summary

Aims:

1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
2. To determine the compliance and complications associated with both strategies.

Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

Study groups:

• Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
• Group II: colonoscopy.

Sample-size calculation: 27,749 subjects in each study group (total: 55,498).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Colorectal Cancer
• Colorectal Neoplasm

Intervention

• Procedure: Immunochemical fecal occult blood test
  Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
• Procedure: Colonoscopy
  Every 10 years, with sedation.

Study Arms

• Active Comparator: Fecal occult blood testing
  Intervention: Procedure: Immunochemical fecal occult blood test
• Active Comparator: Colonoscopy
  Intervention: Procedure: Colonoscopy

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: N Engl J Med. 2016 May 12;374(19):1898.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 19, 2009): 55498
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2021
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men and women aged 50-69 years

Exclusion Criteria:

• Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
• Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)
• Severe comorbidity
• Previous total colectomy
• Not signed informed consent to participate

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00906997
• Other Study ID Numbers: COLONPREV
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Antoni Castells, Hospital Clinic of Barcelona
• Original Responsible Party: Antoni Castells, MD and Enrique Quintero, MD, Gastroenterology Department, Hospital Clínic, Barcelona
• Current Study Sponsor: Hospital Clinic of Barcelona
• Original Study Sponsor: Same as current

Collaborators

• Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.
• Gastrointestinal Oncology Group of the Spanish Gastroenterological Association
• Fundacion Cientifica de la Asociacion Española contra el Cancer
• Instituto de Salud Carlos III

Investigators

• Principal Investigator: Antoni Castells, MD; Hospital Clínic, Barcelona, Spain
• Principal Investigator: Enrique Quintero, MD; Hospital Universitario de Canarias, Tenerife, Spain

• PRS Account: Hospital Clinic of Barcelona
• Verification Date: March 2015