An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain

NCT ID: NCT01205412

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

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Detailed Description

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Conditions

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Human Papillomavirus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Assessed Cohort

Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up

Endocervical samples

Intervention Type PROCEDURE

Endocervical samples collection during routine gynaecological examinations

Interventions

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Endocervical samples

Endocervical samples collection during routine gynaecological examinations

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women ≥ 20 years of age attending a clinic for routine cervical screening OR
* Women ≥ 16 years of age presenting for post-natal check-ups
* Women providing a cervical sample
* Written informed consent or oral-witnessed thumb printed 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 (Note: Enrolment can be delayed until this condition is resolved)
* Pregnant women
* History of hysterectomy
* Known diagnosis of immunosuppression, or patient on immunosuppressives
* Having received one or more doses of human papillomavirus vaccine prior to participating in the study
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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

Manama, , Bahrain

Site Status

Countries

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Bahrain

References

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Moosa K, Alsayyad AS, Quint W, Gopala K, DeAntonio R. An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain. BMC Cancer. 2014 Dec 3;14:905. doi: 10.1186/1471-2407-14-905.

Reference Type DERIVED
PMID: 25466757 (View on PubMed)

Other Identifiers

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112710

Identifier Type: -

Identifier Source: org_study_id