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NCT Number: NCT01158209

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

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 .

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Alexandria, Egypt

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Endocervical samples

Procedure

Endocervical samples collection during routine gynaecological examinations.

Primary outcomes

  1. Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.

    Time frame: Average timeframe: 12 months

Secondary outcomes

  1. Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing

    Time frame: Average timeframe: 12 months

  2. Behavioural risk factors assessed by behavioral questionnaire

    Time frame: At the single study visit (Day 0)

  3. Assessing the awareness of HPV in relation to transmission and cause of cervical cancer

    Time frame: At the single study visit (Day 0)

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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 >= 18 Years of Age, in Egypt

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2010
Registry last updated
Jul 16, 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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