HPV Types Present in External Genital Warts in the Argentinean Population

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Laura Alicia Fleider, University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT01598779
First received: May 11, 2012
Last updated: August 5, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Buenos Aires:

Biospecimen Retention:   Samples With DNA

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


Enrollment: 150
Study Start Date: June 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with genital warts

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598779

Locations
Argentina
IFER
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
University of Buenos Aires
Merck Sharp & Dohme Corp.
Investigators
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: August 5, 2014
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by University of Buenos Aires:
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

Additional relevant MeSH terms:
Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014