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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The summary of this study is to know which HPV types are present in genital warts in Argentinean population.
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Women with genital warts
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Fleider, MD | University of Buenos Aires | Principal Investigator |
| Laura A Fleider, MD | Institute of Gynecology and Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IFER | Buenos Aires | Buenos Aires | 1425 | Argentina |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women age 15-45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Women age 15-45 years, with a lesion suspected of being HPV related were eligible to enter in the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | percentage of participants | 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Fleider | University of Buenos Aires | 541159508000 | 8582 | laurafleider@hotmail.com |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D012749 | Sexually Transmitted Diseases |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D014860 | Warts |
| D000091662 | Genital Diseases |
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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
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
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| D000091642 |
| Urogenital Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |