Last updated: 11/03/2018 14:53:33
An observational, epidemiological study on the prevalence of human papillomavirus types in women in Egypt
GSK study ID
113367
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An observational, epidemiological study on the prevalence of human papillomavirus (HPV) types in women >= 18 years of age, in Egypt
Trial description: 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 .
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.
Timeframe: Average timeframe: 12 months
Secondary outcomes:
Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing
Timeframe: Average timeframe: 12 months
Behavioural risk factors assessed by behavioral questionnaire
Timeframe: At the single study visit (Day 0)
Assessing the awareness of HPV in relation to transmission and cause of cervical cancer
Timeframe: At the single study visit (Day 0)
Interventions:
Procedure/surgery: Endocervical samples
Enrollment:
490
Observational study model:
Cohort
Primary completion date:
2011-24-08
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Human Papillomavirus Infection
Product
SB580299
Collaborators
Not applicable
Study date(s)
October 2010 to August 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
Yes
- Women >= 18 years of age attending a clinic for gynaecological examination.
- Women who agree to provide a cervical sample for human papillomavirus testing.
- Referral for abnormal cervical sample at the current visit.
- Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.
Inclusion and exclusion criteria
Inclusion criteria:
- Women who agree to provide a cervical sample for human papillomavirus testing.
- Written informed consent obtained from the subject.
Women >= 18 years of age attending a clinic for gynaecological examination.
Exclusion criteria:
- 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.
Referral for abnormal cervical sample at the current visit.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2011-24-08
Actual study completion date
2011-24-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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