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


N/A
15 Years
N/A
Not Enrolling
Female
Infections, Papillomavirus, Cervical Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

At least 12 months from the date of subject enrolment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Saudi Arabia: Saudi Food & Drug Authority (SFDA)

Study ID:

111336

NCT ID:

NCT01213459

Start Date:

April 2010

Completion Date:

December 2011

Related Keywords:

  • Infections, Papillomavirus
  • Cervical Cancer
  • Human papillomavirus
  • Uterine Cervical Neoplasms

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