Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population (GWprofamilia)
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|ClinicalTrials.gov Identifier: NCT00847340|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : March 20, 2012
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.
- To determine the HPV genotypes distribution in genital warts in the study population.
- To assess the knowledge about transmission & prevention of HPV infection related diseases
- To determine the direct medical costs of genital warts attention.
|Condition or disease||Intervention/treatment|
|Genital Warts HPV Infections||Procedure: Biopsy Excisional|
Female and male between 18 - 45 years of age living in Bogota, Colombia
Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)
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.
|Study Type :||Observational|
|Actual Enrollment :||342 participants|
|Official Title:||Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
- 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.Other Name: Resection genital warts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847340
|Principal Investigator:||Gustavo J. Hernandez-Suarez, MD||Research & Development Fundation (FID)|