MedDataX Logo

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

NCT ID: NCT01598779

Last Updated: 2015-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Condylomata Acuminata

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

genital warts HPV types Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Papillomavirus Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laura Alicia Fleider

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura A Fleider, MD

Role: PRINCIPAL_INVESTIGATOR

University of Buenos Aires

Laura A Fleider, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Gynecology and Fertility

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IFER

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Genital Warts

Identifier Type: -

Identifier Source: org_study_id