Clinical trial NCT01598779: Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
Official title: Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-05-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with genital warts

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: IFER
Study officials:
affiliation: University of Buenos Aires
name: Laura A Fleider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Gynecology and Fertility
name: Laura A Fleider, MD
role: PRINCIPAL_INVESTIGATOR
References: