Cervical Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 591 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility |
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: |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Ghana | GSK Investigational Site | Accra | |
Ghana | GSK Investigational Site | Kumasi | |
Nigeria | GSK Investigational Site | Ibadan | |
Nigeria | GSK Investigational Site | Lagos | |
South Africa | GSK Investigational Site | Observatory | Western Province |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline | African Organization for Research and Training in Cancer (AORTIC), University of Cape Town |
Ghana, Nigeria, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | 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 | No |
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