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

Study Description

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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.

Condition or disease	Intervention/treatment
Genital Warts; HPV Infections	Procedure: Biopsy Excisional

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	342 participants
Observational Model:	Case-Only
Time Perspective:	Cross-Sectional
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

Groups and Cohorts

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Intervention Details:

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

Outcome Measures

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Biospecimen Retention:   Samples With DNA

Biopsies from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using topications of Monssell solution. Biopsy 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

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.

Contacts and Locations

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Sponsors and Collaborators

La Fundacion para la Investigacion y el Desarrollo

Investigators

Principal Investigator:	Gustavo J. Hernandez-Suarez, MD	Research & Development Fundation (FID)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gustavo Hernandez-Suarez, MD MSc, La Fundacion para la Investigacion y el Desarrollo
ClinicalTrials.gov Identifier:	NCT00847340 History of Changes
Other Study ID Numbers:	protocol V profamilia
First Posted:	February 19, 2009
Last Update Posted:	March 20, 2012
Last Verified:	March 2012

Keywords provided by Gustavo Hernandez-Suarez, La Fundacion para la Investigacion y el Desarrollo:

Genital warts; HPV typing; HPV infections; Condyloma Acuminata

Additional relevant MeSH terms:

Warts; Condylomata Acuminata; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral	Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases