Epidemiology, Costs and Psychosocial Consequences of Geni... | NCT01483794

Studies
Epidemiology, Costs and Psychosocial Consequences of Genital Warts in Valparaiso, Chile

NCT01483794

Sponsor

Universidad de Valparaiso

Status

Unknown status

Last Update Posted

Dec 1, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Condylomata Acuminata

Interventions

Not provided

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1501	Other Identifier	Servicio Salud Valparaiso-San Antonio Chile

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Nov 23, 2011

First Submission Date that Met QC Criteria

Nov 30, 2011

First Posted Date

Dec 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2011

Last Update Posted Date

Dec 1, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carolina San Martin, Principal investigator, Universidad de ValparaisoPrincipal Investigator

Lead Sponsor

Universidad de ValparaisoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso, Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease for the health system and the patient and analyzing possible psychosocial consequences of the condition for the patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Genital warts treated		Patients that have had treatment on their genital warts
Genital warts on treatment		Patients currently being treated for genital warts

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with altered psychosocial tests as a Measure of impact of presenting genital warts.	The psychosocial consequences of presenting genital warts will be assessed.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women 18 years of age or older
Having being diagnosed with genital warts
Consulting the sexual health clinic only for genital warts
Patients accepting to be included in the study

Exclusion Criteria:

Immunodeficiency
HIV positive
Having being diagnosed with cancer or pre-cancerous lesions
Pregnancy
Presenting a sexual transmissible infection other than genital warts.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients attending the public sexual health clinic of Valparaiso, Chile

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heraldo S Povea, MD	Contact	+56-9-91629388		heraldopoveapacci@gmail.com
Carolina San Martin, MD	Contact	+56-9-92895478		caroladc@hotmail.com

Overall Officials

Name	Affiliation	Role
Carolina San Martin, MD	University of Valparaiso, Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sexual Health Clinic,		Valparaíso	Valparaiso	V	Chile

Condition Browse Module

MeSH Terms

ID	Term
D003218	Condylomata Acuminata

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided