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Completed

NCT Number: NCT01213459

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

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.

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Key information

Conditions

Infections, Papillomavirus Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Riyadh, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cervical samples

Procedure

Human papillomavirus detection and typing in cervical samples.

Data Collection

Other

Questionnaire completion

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.

    Time frame: At least 12 months from the date of subject enrolment

Secondary outcomes

  1. 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.

    Time frame: At least 12 months from the date of subject enrolment

  2. Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).

    Time frame: At least 12 months from the date of subject enrolment

  3. Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.

    Time frame: At least 12 months from the date of subject enrolment

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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