An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

NCT ID: NCT01158209

Last Updated: 2012-07-16

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

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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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 .

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 gynaecological examination.

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 \>= 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.
Minimum Eligible Age

18 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

Alexandria, , Egypt

Site Status

GSK Investigational Site

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Shaltout MF, Sallam HN, AbouSeeda M, Moiety F, Hemeda H, Ibrahim A, Sherbini ME, Rady H, Gopala K, DeAntonio R. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study. Int J Infect Dis. 2014 Dec;29:226-31. doi: 10.1016/j.ijid.2014.07.029. Epub 2014 Nov 1.

Reference Type DERIVED
PMID: 25447728 (View on PubMed)

Other Identifiers

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113367

Identifier Type: -

Identifier Source: org_study_id