Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

Condylomata Acuminata Clinical Trial

Official title:

Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598779
• Other study ID #: Genital Warts
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: December 18, 2015
• Start date: June 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2015
• Source: University of Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Observational

Clinical Trial Summary

The summary of this study is to know which HPV types are present in genital warts in Argentinean population.

Description:

This is a prospective study. Patients will be evaluated for the presence of external anogenital warts in our clinic. Biopsy will be performed if patients have genital lesions consistent with genital warts of the external genitalia or perianal area. All patients will be provided with an informed consent for the excision biopsy procedure, before performing the biopsy of the lesion. Biopsy specimens will be held in a formol 10% solution and will be sent to the pathologist. A portion of each sample will be processed for histological analysis, which will be performed by one pathologist. The remainder of each specimen will be saved to extract DNA for PCR analysis. All biopsies will be analyzed by the same pathologist who will confirm the histology of the lesion. A part of the specimen will be kept frozen and if the biopsy confirm genital warts by histology; then the specimen will be analyzed by PCR for the presence of DNA HPV 6 and 11. The PCR analysis will be done by microarrays. Detection is performed in a subtype of array platform system which detects the different types of virus. The reports will be as undetectable / detectable and type.

The study will be conducted in the Institute of Gynecology and Fertility (Institute affiliated with the School of Medicine - University of Buenos Aires).

Chronogram of activities: all activities will be done in a maximum of 60 days

1. st visit: detect external genital warts and firm informed consent and take the biopsy

2. nd visit: inform the result

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• women between 15 and 45 years old, with External Genital Warts

Exclusion Criteria:

• women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Condylomata Acuminata

Locations

Country	Name	City	State
Argentina	IFER	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
University of Buenos Aires	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Papillomavirus (HPV) Types in External Genital Warts (EGW)	150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type	4 months	No