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

November 21, 2012 updated by: GlaxoSmithKline

Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

591

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana
        • GSK Investigational Site
      • Kumasi, Ghana
        • GSK Investigational Site
  • Nigeria
      • Ibadan, Nigeria
        • GSK Investigational Site
      • Lagos, Nigeria
        • GSK Investigational Site
  • South Africa
    • Western Province
      • Observatory, Western Province, South Africa, 7935
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged ≥ 21 years at the time the cervical specimen is taken, diagnosed with cervical lesion macroscopically suggestive of invasive cervical cancer, scheduled for cervical biopsy as per routine procedure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Subjects diagnosed with invasive cervical cancer
Procedure: Collection of cervical cancer tissue samples
Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.
Other: Data collection
Questionnaire completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Average time frame: 6-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Average time frame:6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

University of Cape Town
African Organization for Research and Training in Cancer (AORTIC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on Collection of cervical cancer tissue samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe