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HPV infection has been recognized as the most prevalent sexual transmitted infection worldwide. Burden of many HPV related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated HPV types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention.
Objectives:
Study population
Female and male between 18 - 45 years of age living in Bogota, Colombia
Sample frame
Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)
Analysis
Analysis of the information will be exhaustive. We will calculate prevalence of HPV genotypes in the GW in both sexes separately. Analyses of the survey will include simple frequencies, percentages, and comparison of results related to HPV knowledge with sociodemographic and clinical information. Explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. We will calculate the medical cost of patients enrolled in the study. The treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. We will use national reference cost list (SOAT) to determine the cost of procedures included.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy Excisional | Procedure | Biopsied from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using apply of Monsel solution. Biopsied sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture. |
|
Inclusion Criteria:
Age between 18-45 years.
Lesions suspicious of being HPV related.
The main manifestations of anogenital warts include:
Lesions other than the described above, are not to be biopsied, according to the investigator criteria.
Exclusion Criteria:
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Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA).
Female and male between 18 - 45 years of age living in Bogota, Colombia.
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo J. Hernandez-Suarez, MD | Research & Development Fundation (FID) | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 14, 2012 | |
| Reset | Jan 24, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 14, 2012 | Jan 24, 2013 |
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Biopsies from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using topications of Monssell solution. Biopsy sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |