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

NCT ID: NCT01207999

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

591 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Infections, Papillomavirus Cervical Cancer

Keywords

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Human papillomavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group A

Subjects diagnosed with invasive cervical cancer

Collection of cervical cancer tissue samples

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

Questionnaire completion

Interventions

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Collection of cervical cancer tissue samples

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

Intervention Type PROCEDURE

Data collection

Questionnaire completion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cape Town

OTHER

Sponsor Role collaborator

African Organization for Research and Training in Cancer (AORTIC)

UNKNOWN

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Accra, , Ghana

Site Status

GSK Investigational Site

Kumasi, , Ghana

Site Status

GSK Investigational Site

Ibadan, , Nigeria

Site Status

GSK Investigational Site

Lagos, , Nigeria

Site Status

GSK Investigational Site

Observatory, Western Province, South Africa

Site Status

Countries

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Ghana Nigeria South Africa

Other Identifiers

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109117

Identifier Type: -

Identifier Source: org_study_id