Last updated: 11/03/2018 11:33:37
Study on the prevalence of human papillomavirus types in women >= 15 years of age in the Kingdom of Saudi Arabia
GSK study ID
111336
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 >= 15 years of age, in the Kingdom of Saudi Arabia
Trial description: This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
Timeframe: At least 12 months from the date of subject enrolment
Secondary outcomes:
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.
Timeframe: At least 12 months from the date of subject enrolment
Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).
Timeframe: At least 12 months from the date of subject enrolment
Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.
Timeframe: At least 12 months from the date of subject enrolment
Interventions:
Procedure/surgery: Cervical samples
Other: Data collection
Enrollment:
420
Observational study model:
Case-Only
Primary completion date:
2011-28-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Papillomavirus, Cervical Cancer
Product
SB580299
Collaborators
Not applicable
Study date(s)
April 2010 to December 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
15+ years
Accepts healthy volunteers
No
- Subjects/Subjects’ parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
- Women >=15 years of age attending a clinic for routine cervical screening,
- 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 >=15 years of age attending a clinic for routine cervical screening,
- Written informed consent obtained from the subject and/or subject’s parent/guardian.
Subjects/Subjects’ parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
Exclusion criteria:
- Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
- No cervical sample provided,
- History of hysterectomy,
- Known diagnosis of immunosuppression, or patient on immunosuppressives,
- Pregnant female >=25 years of age.
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
2011-28-12
Actual study completion date
2011-28-12
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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