Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population

NCT ID: NCT00847340

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 342 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-09-30

Brief Summary

HPV infection has been recognized as the most prevalent sexual transmitted infection worldwide. Burden of many HPV related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated HPV types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention.

Objectives:

1. To determine the HPV genotypes distribution in genital warts in the study population.

2. To assess the knowledge about transmission & prevention of HPV infection related diseases

3. To determine the direct medical costs of genital warts attention.

Detailed Description

Study population

Female and male between 18 - 45 years of age living in Bogota, Colombia

Sample frame

Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)

Analysis

Analysis of the information will be exhaustive. We will calculate prevalence of HPV genotypes in the GW in both sexes separately. Analyses of the survey will include simple frequencies, percentages, and comparison of results related to HPV knowledge with sociodemographic and clinical information. Explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. We will calculate the medical cost of patients enrolled in the study. The treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. We will use national reference cost list (SOAT) to determine the cost of procedures included.

Conditions

Genital Warts; HPV Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Biopsy Excisional

Biopsied from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using apply of Monsel solution. Biopsied sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture.

Intervention Type: PROCEDURE

Other Intervention Names

Resection genital warts

Eligibility Criteria

Inclusion Criteria

• Age between 18-45 years.
• Lesions suspicious of being HPV related.
• The main manifestations of anogenital warts include:

• Cauliflower-like condylomata acuminata lesions that usually involve moist surfaces
• keratotic and smooth papular warts, usually on dry surfaces
• subclinical "flat" warts, that can be found on any mucosal or cutaneous surface and, which are probably overseen in the majority of cases.
• Lesions other than the described above, are not to be biopsied, according to the investigator criteria.

Exclusion Criteria

• Not willing to participate
• To be a participant in any HPV vaccine clinical trial study
• Known immune suppressive disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

La Fundacion para la Investigacion y el Desarrollo

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Hernandez-Suarez

MD MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo J. Hernandez-Suarez, MD

Role: PRINCIPAL_INVESTIGATOR

Research & Development Fundation (FID)

Other Identifiers

protocol V profamilia

Identifier Type: -

Identifier Source: org_study_id