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Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

NCT02081742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 349

Last updated 2018-12-13

No results posted yet for this study

Summary

Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain (11,000 deaths per year). Screening of the population over 50 years of age with no significant history (intermediate risk) is recommended, but which screening method is best for promoting adherence in this type of patient has not been well established. There are currently two screening methods that are less invasive than conventional colonoscopy and seem to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods are the colon capsule, which consists in ingesting a capsule that takes photographs of the colon, and virtual colonoscopy, which is a radiological technique.

Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC screening techniques in the intermediate risk population, with diagnostic rates comparable to conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon capsule and virtual colonoscopy with respect to the size and characteristics of the lesions visualised. 3. To compare the participation rates for each screening strategy and identify the factors that influence participation (individual, family, and socioeconomic factors as well as those relating to the doctor).

Conditions

  • Colonic Polyps
  • Adenoma

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • Medtronic - MITG

    collaborator INDUSTRY

  • Begoña González Suárez

    lead OTHER

Principal Investigators

  • Begoña Gonzalez Suarez, PhMD · Hospital Clinic of Barcelona

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-12
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081742 on ClinicalTrials.gov