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OpenTrials
Completed

NCT Number: NCT01598779

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

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

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Key information

Conditions

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

Age range

15 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

IFER

Buenos Aires, 1425, Argentina

About this study

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

  • st visit: detect external genital warts and firm informed consent and take the biopsy
  • nd visit: inform the result

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Human Papillomavirus (HPV) Types in External Genital Warts (EGW)

    Time frame: 4 months

    150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type

Sponsors and collaborators

Lead sponsor

University of Buenos Aires

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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