Condylomata Acuminata Clinical Trial
Official title:
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.
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 Model: Case-Only, Time Perspective: Prospective
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