Condylomata Acuminata
Conditions
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
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
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of Buenos Aires
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | 4 months | 150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type |
Countries
Argentina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Having External Genital Warts Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Patients Having External Genital Warts |
|---|---|
| Age, Continuous | 28.48 years |
| Region of Enrollment Argentina | 150 participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type
Time frame: 4 months
Population: Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | HPV 11 | 12.66 percentage of participants |
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | HPV 6 & 11 | 0.66 percentage of participants |
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | HPV 6 | 80 percentage of participants |
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | HPV 16 | 2 percentage of participants |
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | HPV 73 | 0.66 percentage of participants |
| Women With External Genital Warts | Human Papillomavirus (HPV) Types in External Genital Warts (EGW) | Negative | 4 percentage of participants |