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

NCT01213459 | Completed

• 1 other identifier: 111336
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infections, Papillomavirus; Cervical Cancer

Keywords

Human papillomavirus

Outcome Measures

Primary Outcomes (1)

• Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.

  At least 12 months from the date of subject enrolment

Secondary Outcomes (3)

• 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.

  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).

  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.

  At least 12 months from the date of subject enrolment

Study Arms (1)

Cohort A

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

Procedure: Cervical samples; Other: Data collection

Interventions

Cervical samples PROCEDURE

Human papillomavirus detection and typing in cervical samples.

Cohort A

Data collection OTHER

Questionnaire completion

Cohort A

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women \>=15 years of age attending out-patient departments of primary, secondary or tertiary care centers for routine cervical screening, in the Kingdom of Saudi Arabia.

You may qualify if:

• 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.

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,
• No cervical sample provided,
• History of hysterectomy,
• Known diagnosis of immunosuppression, or patient on immunosuppressives,
• Pregnant female \>=25 years of age.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Riyadh, 11211, Saudi Arabia

Location

GSK Investigational Site

Riyadh, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 25496614 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Cervical samples

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

Data Collection

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; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

SA (2)