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Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

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ClinicalTrials.gov Identifier: NCT01598779
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Laura Alicia Fleider, University of Buenos Aires

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

Condition or disease
Condylomata Acuminata

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
Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
Study Start Date : June 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Warts Warts

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Human Papillomavirus (HPV) Types in External Genital Warts (EGW) [ Time Frame: 4 months ]
    150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type


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

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598779


Locations
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Argentina
IFER
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
University of Buenos Aires
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Laura A Fleider, MD University of Buenos Aires
Principal Investigator: Laura A Fleider, MD Institute of Gynecology and Fertility
More Information
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Responsible Party: Laura Alicia Fleider, Physician, University of Buenos Aires
ClinicalTrials.gov Identifier: NCT01598779    
Other Study ID Numbers: Genital Warts
First Posted: May 15, 2012    Key Record Dates
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015
Last Verified: December 2015
Keywords provided by Laura Alicia Fleider, 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:
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Condylomata Acuminata
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Infections
Warts
Papillomavirus Infections
 DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases