Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00847340
Other study ID # protocol V profamilia
Secondary ID
Status Completed
Phase N/A
First received February 17, 2009
Last updated March 19, 2012
Start date December 2009
Est. completion date September 2010

Study information

Verified date March 2012
Source La Fundacion para la Investigacion y el Desarrollo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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:

1. To determine the HPV genotypes distribution in genital warts in the study population.

2. To assess the knowledge about transmission & prevention of HPV infection related diseases

3. To determine the direct medical costs of genital warts attention.


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.


Recruitment information / eligibility

Status Completed
Enrollment 342
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Not willing to participate

- To be a participant in any HPV vaccine clinical trial study

- Known immune suppressive disease.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy Excisional
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
La Fundacion para la Investigacion y el Desarrollo
See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT01651949 - Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003) Phase 3
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Terminated NCT01468636 - A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts Phase 4
Recruiting NCT03296397 - Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response Phase 3
Active, not recruiting NCT05314023 - Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053) Phase 3
Completed NCT00674739 - Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts Phase 3
Recruiting NCT03948321 - Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts N/A
Completed NCT00862810 - Alternate Dosing Schedules Study for HPV Vaccine Phase 4
Completed NCT02280642 - Alternate Dosing Schedules Study for HPV Vaccine (ADS) Phase 4
Completed NCT00092482 - Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED) Phase 3
Completed NCT02188004 - The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases
Completed NCT01553994 - Effectiveness Study of Gardasil on Condyloma N/A
Completed NCT00189293 - Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts Phase 4
Active, not recruiting NCT00092534 - Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015) Phase 3
Completed NCT02462187 - Topical NVN1000 for the Treatment of External Genital and Perianal Warts Phase 2
Completed NCT00501137 - A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine Phase 3
Active, not recruiting NCT02750202 - Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts Phase 3