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

NCT01158209 | Completed

• 1 other identifier: 113367
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 2

Brief Summary

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 .

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

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

  Average timeframe: 12 months

Secondary Outcomes (3)

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

  Average timeframe: 12 months

• Behavioural risk factors assessed by behavioral questionnaire

  At the single study visit (Day 0)

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

  At the single study visit (Day 0)

Study Arms (1)

Assessed cohort

Subjects attending out-patient health services for gynaecological examination.

Procedure: Endocervical samples

Interventions

Endocervical samples PROCEDURE

Endocervical samples collection during routine gynaecological examinations.

Assessed cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women \>= 18 attending out-patient departments of primary, secondary or tertiary care centres for gynaecological examination and agreeing to provide a cervical sample for human papillomavirus testing.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Alexandria, Egypt

Location

GSK Investigational Site

Cairo, Egypt

Location

Related Publications (1)

• Shaltout MF, Sallam HN, AbouSeeda M, Moiety F, Hemeda H, Ibrahim A, Sherbini ME, Rady H, Gopala K, DeAntonio R. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study. Int J Infect Dis. 2014 Dec;29:226-31. doi: 10.1016/j.ijid.2014.07.029. Epub 2014 Nov 1.

  PMID: 25447728 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Endocervical samples

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: July 8, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 16, 2012

Record last verified: 2011-10

Locations

EG (2)