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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01158209
Other study ID # 113367
Secondary ID
Status Completed
Phase N/A
First received June 11, 2010
Last updated July 12, 2012
Start date October 2010
Est. completion date August 2011

Study information

Verified date October 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Completed
Enrollment 490
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Endocervical samples
Endocervical samples collection during routine gynaecological examinations.

Locations

Country Name City State
Egypt GSK Investigational Site Alexandria
Egypt GSK Investigational Site Cairo

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing. Average timeframe: 12 months No
Secondary Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing Average timeframe: 12 months No
Secondary Behavioural risk factors assessed by behavioral questionnaire At the single study visit (Day 0) No
Secondary Assessing the awareness of HPV in relation to transmission and cause of cervical cancer At the single study visit (Day 0) No
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