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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906997
First Posted: May 21, 2009
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose

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).


Condition Intervention Phase
Colorectal Cancer Colorectal Neoplasm Procedure: Immunochemical fecal occult blood test Procedure: Colonoscopy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Antoni Castells, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Colorectal cancer-related mortality [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55498
Study Start Date: November 2008
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fecal occult blood testing Procedure: Immunochemical fecal occult blood test
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
Active Comparator: Colonoscopy Procedure: Colonoscopy
Every 10 years, with sedation.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906997


Locations
Spain
Hospital del Mar
Barcelona, Spain
Hospital Clínico
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Meixoeiro
Ourense, Spain
Hospital de Donosti
San Sebastián, Spain
Hospital Universitario de Canarias
Tenerife, Spain
Comunidad Valencia
Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Salas D, Vanaclocha M, Ibáñez J, Molina-Barceló A, Hernández V, Cubiella J, Zubizarreta R, Andreu M, Hernández C, Pérez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentín 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, Álvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernández C, Jover R, Hijona E, Portillo I, Enríquez-Navascués JM, Hernández V, Martínez-Turnes A, Menéndez-Villalva C, González-Mao C, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Sopeña F, González-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo À, Pellisé M, Balaguer F, Ono A, Cruzado J, Pérez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrándiz J, González-Hernández 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, Martínez-Turnes A, Martínez-Ares D, Estevez P, Cid E, Vidal MC, López-Martínez 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 Á, Quintero E, Castells A, Sarasqueta C, Cubiella J, Hernandez V, Morillas JD, Perez-Fernández 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 Á, Andreu M, Carballo F, Morillas JD, Hernández C, Jover R, Montalvo I, Arenas J, Laredo E, Hernández V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Roncales MP, Polo-Tomás M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Pérez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Díaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, González-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.

Responsible Party: Antoni Castells, Co-principal investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00906997     History of Changes
Other Study ID Numbers: COLONPREV
First Submitted: May 19, 2009
First Posted: May 21, 2009
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Antoni Castells, Hospital Clinic of Barcelona:
Colorectal cancer
Screening
Prevention
Fecal occult blood test
Colonoscopy
Colorectal neoplasm
Randomized clinical trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases


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