Clinical Trial: Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: COMPARATIVE STUDY OF THE EFFICACY OF TWO NON-INVASIVE IMAGING TECHNIQUES IN POPULATION SCREENING FOR COLORECTAL CANCER (CRC): COLON CAPSULE AND VIRTUAL COLONOSCOPY

Brief 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).


Detailed Summary:

Based on the fact that CRC is an important healthcare issue and that there is enough evidence to show that this disease, if diagnosed early, is curable and at a reasonable cost, the European Community Council, in 2003, issued directives that member states would make population screening for CRC a priority in their healthcare planning. Thus, Spain's Ministry of Health and Consumer Affairs included population screening for CRC in its National Healthcare Plan as a priority action within the Comprehensive Plan against Cancer (PICA), which was required to be implemented by the year 2007.

The screening tools we currently have are not ideal either because, like the test for faecal occult blood (FOBT), which is the most evaluated to date, they are not sensitive enough or, like conventional colonoscopy, they are not risk-free. All of this means that population adherence is limited.

In this study, we wish to compare two new diagnostic techniques for CRC (colon capsule and virtual colonoscopy) that, although recently introduced into the healthcare system, have sufficient scientific evidence to confirm that they are effective and possibly cost-effective techniques.

The population we are concerned with in this study is the healthy population—men and women 50-69 years of age with no significant history. Therefore, the screening method we offer must be the least invasive and the most comfortable method possible so that good compliance is achieved. This means techniques that are painless and essentially harmless in comparison with conventional colonoscopy. If we were to observe higher concordance between these techniques and conventional colonoscopy in terms of detecting lesions, we would use the latter strictly for therapeutic reasons in this population, thereby significantly reduci
Sponsor: Begoña González Suárez

Current Primary Outcome: Percentage of colon lesions detected by virtual colonoscopy and colon capsule [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of polypoid lesions and colorectal cancer (CRC) in the intermediate risk population [ Time Frame: 3 years ]
  • Number of complications associated with each of the screening strategies [ Time Frame: 3 years ]
  • Rate of false positives and false negatives obtained with virtual colonoscopy and colon capsule [ Time Frame: 3 years ]
  • percentage of participation and adherence to the suggested screening programme in the population studied [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: September 16, 2013
Date Started: February 2013
Date Completion: July 2016
Last Updated: August 25, 2015
Last Verified: August 2015