HPV Types Present in External Genital Warts in the Argentinean Population
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
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Laura A Fleider, MD
Principal Investigator
University of Buenos Aires
Argentina: Human Research Bioethics Committee
Genital Warts
NCT01598779
June 2012
June 2013
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