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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gustavo Hernandez-Suarez, La Fundacion para la Investigacion y el Desarrollo
ClinicalTrials.gov Identifier:
NCT00847340
First received: February 17, 2009
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Genital Warts
HPV Infections
 Procedure: Biopsy Excisional

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Warts
U.S. FDA Resources

Further study details as provided by La Fundacion para la Investigacion y el Desarrollo:

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.

Enrollment: 342
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847340

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

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 
Study First Received: February 17, 2009
Last Updated: March 19, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016