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

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ClinicalTrials.gov Identifier: NCT01158209
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Human Papillomavirus Infection Procedure: Endocervical samples

Study Design

Study Type : Observational
Actual Enrollment : 490 participants
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
Study Start Date : October 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
Assessed cohort
Subjects attending out-patient health services for gynaecological examination.
Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Behavioural risk factors assessed by behavioral questionnaire [ Time Frame: At the single study visit (Day 0) ]
  3. Assessing the awareness of HPV in relation to transmission and cause of cervical cancer [ Time Frame: At the single study visit (Day 0) ]

Biospecimen Retention:   Samples With DNA
Endocervical samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01158209     History of Changes
Other Study ID Numbers: 113367
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: October 2011

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections