Genital WartsGWprofamiliaNCT00847340
Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population
An observational study of Genital Warts and HPV Infections, run by La Fundacion para la Investigacion y el Desarrollo.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Genital Warts, HPV Infections
- What is being tested?
- Biopsy Excisional
- Type of treatment
- Surgery or procedure
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Age between 18-45 years.
- Lesions suspicious of being HPV related.
- The main manifestations of anogenital warts include:
- Cauliflower-like condylomata acuminata lesions that usually involve moist surfaces
- keratotic and smooth papular warts, usually on dry surfaces
- subclinical "flat" warts, that can be found on any mucosal or cutaneous surface and, which are probably overseen in the majority of cases.
- Lesions other than the described above, are not to be biopsied, according to the investigator criteria.
Who cannot join
- Not willing to participate
- To be a participant in any HPV vaccine clinical trial study
- Known immune suppressive disease.
About this study
Official title: Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.
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:
- To determine the HPV genotypes distribution in genital warts in the study population.
- To assess the knowledge about transmission \& prevention of HPV infection related diseases
- To determine the direct medical costs of genital warts attention.
Read the detailed description
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.
- Conditions
- Genital Warts, HPV Infections
- Being tested
- Biopsy Excisional
- Keywords
- Genital warts, HPV typing, HPV infections, Condyloma Acuminata
- Medical subject headings
- Condylomata Acuminata, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ExcisionalProcedure or surgery
Also called Resection genital warts
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital WartsStudies 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
- Cross-sectional
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Fundacion para la Investigacion y el Desarrollo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Hernandez-Suarez, La Fundacion para la Investigacion y el Desarrollo
- Investigators
- Gustavo J. Hernandez-Suarez, MD, Principal investigator, Research & Development Fundation (FID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847340
- Sponsor's protocol ID
- protocol V profamilia
- Acronym
- GWprofamilia
- Status last verified
- Mar 2012
- First submitted
- 17 Feb 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.
- ClinicalTrials.gov ID
- NCT00847340
- Acronym / sponsor ID
- GWprofamilia / protocol V profamilia
- Conditions
- Genital Warts, HPV Infections
- Keywords
- Genital warts, HPV typing, HPV infections, Condyloma Acuminata
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- La Fundacion para la Investigacion y el DesarrolloUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the HPV genotypes distribution in genital warts in the study population.
- To assess the knowledge about transmission \& prevention of HPV infection related diseases
- To determine the direct medical costs of genital warts attention.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Not willing to participate
- To be a participant in any HPV vaccine clinical trial study
- Known immune suppressive disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ExcisionalAlso: Resection genital wartsBiopsied 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. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
Related trials for Genital Warts
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
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.
Gustavo J. Hernandez-Suarez, MD principal investigator
Research & Development Fundation (FID)
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Warts and HPV Infections, run by La Fundacion para la Investigacion y el Desarrollo.
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 7 inclusion and 3 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 20 Mar 2012.