HPV Types Present in External Genital Warts in the Argentinean Population
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Purpose
The summary of this study is to know which HPV types are present in genital warts in Argentinean population.
| Condition |
|---|
|
Condylomata Acuminata |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | HPV Types Present in External Genital Warts in the Argentinean Population |
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
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Women with genital warts
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
Contacts and Locations| Contact: Laura A Fleider, MD | (+5411) 4803-3756 | laurafleider@hotmail.com |
| Argentina | |
| IFER | Recruiting |
| Buenos Aires, Argentina, 1425 | |
| Principal Investigator: Laura Fleider, MD | |
| Principal Investigator: | Laura A Fleider, MD | University of Buenos Aires |
| Principal Investigator: | Laura A Fleider, MD | Institute of Gynecology and Fertility |
More Information
No publications provided
| Responsible Party: | Laura Alicia Fleider, Phisician, University of Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT01598779 History of Changes |
| Other Study ID Numbers: | Genital Warts |
| Study First Received: | May 11, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Argentina: Human Research Bioethics Committee |
Keywords provided by University of Buenos Aires:
|
Sexually Transmitted Diseases, Viral 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 |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases, Viral Condylomata Acuminata Warts Papillomavirus Infections DNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013