Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

Completed

• Conditions: Cervical Cancer; Infections, Papillomavirus
• Interventions: Procedure: Collection of cervical cancer tissue samples; Other: Data collection

• Registration Number: NCT01207999
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 591

Inclusion Criteria

• A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer.
• Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date.
• Written or oral-witnessed informed consent obtained from the subject prior to any study procedure.
• No prior chemo- or radiotherapy for cervical cancer.

Exclusion Criteria

Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Data collection	Subjects diagnosed with invasive cervical cancer
Group A	Collection of cervical cancer tissue samples	Subjects diagnosed with invasive cervical cancer

Primary Outcome Measures

Name	Time	Method
Occurrence of any of the human papillomavirus types (HPV-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with invasive cervical cancer	Average time frame: 6-12 months
Occurrence of any of the human papillomavirus types (human papillomavirus-16, 18, 31, 33, 35, 45, 52 and 58) among the women diagnosed with squamous cell carcinoma	Average time frame: 6-12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer	Average time frame:6-12 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇿🇦 Observatory, Western Province, South Africa