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

Genital Warts Clinical Trial

— GWprofamilia  

Official title:

Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847340
• Other study ID #: protocol V profamilia
• Status: Completed
• Phase: N/A
• First received: February 17, 2009
• Last updated: March 19, 2012
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: La Fundacion para la Investigacion y el Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• HPV Infections
• Warts

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
La Fundacion para la Investigacion y el Desarrollo