Text Size

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01158209
First received: June 11, 2010
Last updated: July 12, 2012
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .


Condition Intervention
Human Papillomavirus Infection
 Procedure: Endocervical samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 18 Years of Age, in Egypt

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing. [ Time Frame: Average timeframe: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing [ Time Frame: Average timeframe: 12 months ] [ Designated as safety issue: No ]
  • Behavioural risk factors assessed by behavioral questionnaire [ Time Frame: At the single study visit (Day 0) ] [ Designated as safety issue: No ]
  • Assessing the awareness of HPV in relation to transmission and cause of cervical cancer [ Time Frame: At the single study visit (Day 0) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Endocervical samples


Enrollment: 490
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Assessed cohort
Subjects attending out-patient health services for gynaecological examination.
 Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women >= 18 attending out-patient departments of primary, secondary or tertiary care centres for gynaecological examination and agreeing to provide a cervical sample for human papillomavirus testing.

Criteria

Inclusion Criteria:

  • Women >= 18 years of age attending a clinic for gynaecological examination.
  • Women who agree to provide a cervical sample for human papillomavirus testing.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Referral for abnormal cervical sample at the current visit.
  • Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.
  • History of hysterectomy.
  • Known diagnosis of immunosuppression, or patient on immunosuppressives.
  • Pregnant women.
  • Having received one or more doses of HPV vaccine prior to participating in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158209

Locations
Egypt
GSK Investigational Site
Alexandria, Egypt
GSK Investigational Site
Cairo, Egypt
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01158209     History of Changes
Other Study ID Numbers: 113367
Study First Received: June 11, 2010
Last Updated: July 12, 2012
Health Authority: Egypt: Ministry of Health

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013