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Anogenital Wart Burden and Cost of Illnesses
This study is currently recruiting participants.
Verified by Mahidol University, August 2008
Sponsored by: Mahidol University
Information provided by: Mahidol University
ClinicalTrials.gov Identifier: NCT00749294
  Purpose

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.


Condition
Warts

MedlinePlus related topics: Genital Warts Warts
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Measurement of Anogenital Wart Burden, and Cost of Illnesses in Bangkok

Further study details as provided by Mahidol University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation

Detailed Description:

An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749294

Contacts
Contact: Dr. Jittima Dhitavat 662 6435599 tmjdt@mahidol.ac.th

Locations
Thailand
Clinical Infectious Diseases Research Unit Recruiting
Bangkok, Thailand, 10400
Contact: Prof. Punnee Pitisuttithum, M.B.,B.S.     662 6435599     tmppt@mahidol.ac.th    
Principal Investigator: Dr. Tosaporn Ruengkris            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Prof. Punnee Pitisuttithum, M.B.,B.S. Mahidol University
  More Information

Responsible Party: Mahidol University ( Prof. Punnee Pitisuttithum )
Study ID Numbers: THALS1570
Study First Received: September 8, 2008
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00749294  
Health Authority: Thailand: Ethical Committee

Study placed in the following topic categories:
Virus Diseases
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Warts
Skin Diseases
Condyloma acuminatum
Condylomata Acuminata
Sexually Transmitted Diseases
Condyloma
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:
Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009