NCT00749294

Brief Summary

The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

1.2 years

First QC Date

September 8, 2008

Last Update Submit

August 6, 2010

Conditions

Study Arms (1)

Observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting with anogenital warts, conducted at Rajavithi General Hospital and Bangrak Hospital

You may qualify if:

  • Subject is 18 years of age or older and has anogenital warts
  • Physician confirmed clinical diagnosis of anogenital warts
  • Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent
  • Subject will be available for the study follow up period

You may not qualify if:

  • Subject is unable to give informed consent
  • Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Infectious Diseases Research Unit

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Punnee Pitisuttithum, M.B.,B.S.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations