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An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain


N/A
16 Years
N/A
Not Enrolling
Female
Human Papillomavirus Infection

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Trial Information

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Average time frame: 12 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Kingdom of Bahrain: Ministry of Health

Study ID:

112710

NCT ID:

NCT01205412

Start Date:

October 2010

Completion Date:

November 2011

Related Keywords:

  • Human Papillomavirus Infection
  • Warts
  • Papillomavirus Infections

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