## Protocol Section
### Identification Module
**NCT ID:** NCT01598779

**Brief Title:** Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

**Official Title:** Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population

#### Organization Study ID Info
**ID:** Genital Warts
#### Organization
**Class:** OTHER
**Full Name:** University of Buenos Aires
### Status Module
#### Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-12-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-12-21

**Type:** ESTIMATED

**Results First Submit Date:** 2014-12-09

**Results First Submit QC Date:** 2015-12-18

#### Start Date
**Date:** 2012-06

**Status Verified Date:** 2015-12

#### Study First Post Date
**Date:** 2012-05-15
**Type:** ESTIMATED
**Study First Submit Date:** 2012-05-11
**Study First Submit QC Date:** 2012-05-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Buenos Aires

#### Responsible Party

**Investigator Affiliation:** University of Buenos Aires

**Investigator Full Name:** Laura Alicia Fleider

**Investigator Title:** Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Condylomata Acuminata

**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

### Design Module

#### Bio Spec

**Description:** 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

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type

**Measure:** Human Papillomavirus (HPV) Types in External Genital Warts (EGW)

**Time Frame:** 4 months

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 15 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Women with genital warts

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Buenos Aires

**Country:** Argentina

**Facility:** IFER

**Zip:** 1425

#### Overall Officials

**Official 1:**

**Affiliation:** University of Buenos Aires

**Name:** Laura A Fleider, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Institute of Gynecology and Fertility

**Name:** Laura A Fleider, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000014860

- Term: Warts

- ID: D000030361

- Term: Papillomavirus Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000017193

- Term: Skin Diseases, Viral

- ID: D000014412

- Term: Tumor Virus Infections

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23687

- Name: Papillomavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17603

- Name: Warts

- Relevance: LOW

- As Found: Unknown

- ID: M6443

- Name: Condylomata Acuminata

- Relevance: HIGH

- As Found: Genital Warts

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17162

- Name: Tumor Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19501

- Name: Skin Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003218

- Term: Condylomata Acuminata

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Patients Having External Genital Warts

**Description:** 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

**ID:** EG000

**Other Num at Risk:** 150

**Serious Number At Risk:** 150

**Title:** Patients Having External Genital Warts

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 150

**Units:** Participants

### Group

**ID:** BG000

**Title:** Patients Having External Genital Warts

**Description:** 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

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 15

**Upper Limit:** 45

**Value:** 28.48

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 150

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 150

**Class Title:** Argentina

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Women age 15-45 years, with a lesion suspected of being HPV related were eligible to enter in the study.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** 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.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** laurafleider@hotmail.com
**Organization:** University of Buenos Aires
**Phone:** 541159508000
**Phone Extension:** 8582
**Title:** Dr. Laura Fleider
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.66
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.66
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.66
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type
**Parameter Type:** NUMBER
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 4 months
**Title:** Human Papillomavirus (HPV) Types in External Genital Warts (EGW)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 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 were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical "flat" warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.

Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
**ID:** OG000
**Title:** Women With External Genital Warts
### Participant Flow Module
#### Group
**Description:** 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
**ID:** FG000
**Title:** Patients Having External Genital Warts
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 150
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 150
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True