Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

NCT02081742 | Completed DMC

• 1 other identifier: CCV-003
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

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).

Conditions

Colonic Polyps; Adenoma

Keywords

Colonoscopy, CT colonography, Colon capsule

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with colorectal neoplastic lesions detected by colon capsule adn CTC

  The primary endpoint was to compare the performance characteristics of CCE and CTC in detecting patients with colorectal neoplastic lesions, using colonoscopy as gold standard.

  3 years

Secondary Outcomes (4)

• number of advanced polypoid lesions and colorectal cancer (CRC) detected by CCE and CTC

  3 years

• Number of complications associated with each of the screening strategies

  3 years

• Rate of false positives and false negatives obtained with CTC and colon capsule

  3 years

• Number of false negative lesions detected by CTC or colon capsule

  3 years

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 reducing the complications associated with it

You may qualify if:

• The main objective in this study is compare two non-invasive techniques in the study of colorectal cancer. When we calculate the sample size we observed that we need more than 1000 patients per group. In this moment this study is very expensive and it is not feasible. Our proposal is include population with a higher prevalence of lesions: individuals with positive FIT (fecal immunochemical test) in which the prevalence of lesions is 60%. In this case, sample size is reduced considerably.
• The eligible population will be men and women, 50-69 years old, with no known risk factors and positive FIT.

You may not qualify if:

• Individuals who have symptoms suggestive of colorectal disease (rectorrhagia, change in bowel movement frequency, constitutional syndrome, anaemia).
• History of inflammatory bowel disease, colorectal polyposis, colorectal adenoma or CRC, and total or partial colectomy.
• History of familial adenomatous polyposis or other hereditary polyposis syndromes; hereditary colorectal cancer not associated with polyposis (diagnosed by the presence of germinal mutation in the DNA repair genes and/or by fulfilment of the Amsterdam II criteria);
• Severe co-morbidity that carries a poor short-term prognosis (disease with an average life expectancy of less than 5 years) or a chronic illness that involves significant limitation of physical activity.
• Contraindication to undergoing colon capsule or virtual colonoscopy.

Sponsors & Collaborators

• Begoña González Suárez: lead
• Norgine: collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

• Gonzalez-Suarez B, Pages M, Araujo IK, Romero C, Rodriguez de Miguel C, Ayuso JR, Pozo A, Vila-Casadesus M, Serradesanferm A, Gines A, Fernandez-Esparrach G, Pellise M, Lopez-Ceron M, Flores D, Cordova H, Sendino O, Grau J, Llach J, Serra-Burriel M, Cardenas A, Balaguer F, Castells A. Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study. BMC Med. 2020 Sep 18;18(1):255. doi: 10.1186/s12916-020-01717-4.

  PMID: 32943059 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Begoña Gonzalez Suarez, PhMD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: March 7, 2014
• Study Start: March 12, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

ES (1)