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

NCT01205412 | Completed

• 1 other identifier: 112710
• Study Type: observational
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.

  Average time frame: 12 months

Secondary Outcomes (3)

• Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.

  Average time frame: 12 months

• Behavioural risk factors

  During visit 1 (day 0)

• Awareness of HPV in relation to transmission and cause of cervical cancer

  Average time frame: 12 months

Study Arms (1)

Assessed Cohort

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

Procedure: Endocervical samples

Interventions

Endocervical samples PROCEDURE

Endocervical samples collection during routine gynaecological examinations

Assessed Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Manama, Bahrain

Location

Related Publications (1)

• 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.

  PMID: 25466757 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Endocervical samples

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

BA (1)