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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014