Condylomata AcuminataNCT01598779
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
An observational study of Condylomata Acuminata, run by University of Buenos Aires at 1 site in Argentina.
Trial summary
The summary of this study is to know which HPV types are present in genital warts in Argentinean population. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condylomata Acuminata
- How many people
- 150 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2012to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with genital warts
Who may be able to join
- women between 15 and 45 years old, with External Genital Warts
Who cannot join
- women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
Trial locations and contacts
1 site in 1 country.
About this study
The summary of this study is to know which HPV types are present in genital warts in Argentinean population.
Read the 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
- st visit: detect external genital warts and firm informed consent and take the biopsy
- nd visit: inform the result
- 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
- Medical subject headings
- Condylomata Acuminata, Sexually Transmitted Diseases, Skin Diseases, Viral, Tumor Virus Infections, Skin Diseases, Infectious, Skin Diseases, Papillomavirus Infections, DNA Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Laura Alicia Fleider, University of Buenos Aires
- Investigators
- Laura A Fleider, MD, Principal investigator, University of Buenos AiresLaura A Fleider, MD, Principal investigator, Institute of Gynecology and Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598779
- Sponsor's protocol ID
- Genital Warts
- Status last verified
- Dec 2015
- First submitted
- 11 May 2012
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population
- ClinicalTrials.gov ID
- NCT01598779
- Acronym / sponsor ID
- Genital Warts
- Conditions
- Condylomata Acuminata
- Keywords
- genital warts, HPV types, Sexually Transmitted Diseases, Skin Diseases, Viral, Tumor Virus Infections, Skin Diseases, Infectious, Skin Diseases, Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 21 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- st visit: detect external genital warts and firm informed consent and take the biopsy
- nd visit: inform the result
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with genital warts
Key inclusion criteria (1 listed)
- women between 15 and 45 years old, with External Genital Warts
Key exclusion criteria (1 listed)
- women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Fleider, MD principal investigator
University of Buenos Aires
Laura A Fleider, MD principal investigator
Institute of Gynecology and Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Condylomata Acuminata, run by University of Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papillomavirus (HPV) Types in External Genital Warts (EGW) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.