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

NCT00847340 | Completed DMC

• 1 other identifier: protocol V profamilia
• Study Type: observational
• Target: 342
• Locations: 0 countries
• Sites: N/A

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. 1.To determine the HPV genotypes distribution in genital warts in the study population.
2. 2.To assess the knowledge about transmission \& prevention of HPV infection related diseases
3. 3.To determine the direct medical costs of genital warts attention.

Conditions

Genital Warts; HPV Infections

Keywords

Genital warts; HPV typing; HPV infections; Condyloma Acuminata

Interventions

Biopsy Excisional PROCEDURE

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.

Also known as: Resection genital warts

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Not willing to participate
• To be a participant in any HPV vaccine clinical trial study
• Known immune suppressive disease.

Sponsors & Collaborators

• La Fundacion para la Investigacion y el Desarrollo: lead

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.

MeSH Terms

Conditions

Condylomata Acuminata; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo J. Hernandez-Suarez, MD

  Research & Development Fundation (FID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 20, 2012

Record last verified: 2012-03