HPV Types Present in External Genital Warts in the Argentinean Population
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||HPV Types Present in External Genital Warts in the Argentinean Population|
|Study Start Date:||June 2012|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598779
|Buenos Aires, Argentina, 1425|
|Principal Investigator:||Laura A Fleider, MD||University of Buenos Aires|
|Principal Investigator:||Laura A Fleider, MD||Institute of Gynecology and Fertility|