Trial record 2 of 367 for:    (human papillomavirus OR hpv) AND (woman OR women OR female)

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
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 April 17, 2014