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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01213459
First received: October 1, 2010
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Infections, Papillomavirus
Cervical Cancer
Procedure: Cervical samples
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cervical samples


Enrollment: 420
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Women ≥15 years of age attending out-patient departments for routine cervical screening in the Kingdom of Saudi Arabia.
Procedure: Cervical samples
Human papillomavirus detection and typing in cervical samples.
Other: Data collection
Questionnaire completion

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213459

Locations
Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia
GSK Investigational Site
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01213459     History of Changes
Other Study ID Numbers: 111336
Study First Received: October 1, 2010
Last Updated: November 21, 2012
Health Authority: Saudi Arabia: Saudi Food & Drug Authority (SFDA)

Keywords provided by GlaxoSmithKline:
Human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014