Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

NCT ID: NCT01213459

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infections, Papillomavirus Cervical Cancer

Keywords

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Human papillomavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.

Cervical samples

Intervention Type PROCEDURE

Human papillomavirus detection and typing in cervical samples.

Data collection

Intervention Type OTHER

Questionnaire completion

Interventions

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Cervical samples

Human papillomavirus detection and typing in cervical samples.

Intervention Type PROCEDURE

Data collection

Questionnaire completion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,
* Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion Criteria

* Referral for abnormal cervical sample at the current visit,
* 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.
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Riyadh, , Saudi Arabia

Site Status

GSK Investigational Site

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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AlObaid A, Al-Badawi IA, Al-Kadri H, Gopala K, Kandeil W, Quint W, Al-Aker M, DeAntonio R. Human papillomavirus prevalence and type distribution among women attending routine gynecological examinations in Saudi Arabia. BMC Infect Dis. 2014 Dec 14;14:643. doi: 10.1186/s12879-014-0643-8.

Reference Type DERIVED
PMID: 25496614 (View on PubMed)

Other Identifiers

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111336

Identifier Type: -

Identifier Source: org_study_id