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


N/A
18 Years
45 Years
Not Enrolling
Both
Genital Warts, HPV Infections

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Principal Investigator

Gustavo J. Hernandez-Suarez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Research & Development Fundation (FID)

Authority:

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study ID:

protocol V profamilia

NCT ID:

NCT00847340

Start Date:

December 2009

Completion Date:

September 2010

Related Keywords:

  • Genital Warts
  • HPV Infections
  • Genital warts
  • HPV typing
  • HPV infections
  • Condyloma Acuminata
  • Condylomata Acuminata
  • Warts

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