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

N/ACompletedNCT01207999

GlaxoSmithKline591 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

591

Conditions

Infections, Papillomavirus Cervical Cancer

Interventions

Collection of cervical cancer tissue samplesPROCEDURE

Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.

Data collectionOTHER

Questionnaire completion

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (5)

GSK Investigational Site

Accra, Ghana

GSK Investigational Site

Kumasi, Ghana

GSK Investigational Site

Ibadan, Nigeria

GSK Investigational Site

Lagos, Nigeria

GSK Investigational Site

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Average time frame: 6-12 months

Secondary Outcomes

Proportion of squamous cell carcinoma cases versus adenocarcinoma and other histologic tumour types of invasive cancer among the women diagnosed with invasive cervical cancer

Time frame: Average time frame:6-12 months

Data from ClinicalTrials.gov

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