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

NCT01598779 | Completed Results DMC

• 1 other identifier: Genital Warts
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Condylomata Acuminata

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with genital warts

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Buenos Aires: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

IFER

Buenos Aires, Buenos Aires, 1425, Argentina

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Condylomata Acuminata; 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

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Warts; Genital Diseases; Urogenital Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Laura Fleider
• Organization: University of Buenos Aires

laurafleider@hotmail.com

541159508000

Study Officials

• Laura A Fleider, MD

  University of Buenos Aires

  PRINCIPAL INVESTIGATOR

• Laura A Fleider, MD

  Institute of Gynecology and Fertility

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 21, 2015
• Results First Posted: December 21, 2015

Record last verified: 2015-12

Locations

AR (1)