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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01207999
Other study ID # 109117
Secondary ID
Status Completed
Phase N/A
First received September 22, 2010
Last updated November 21, 2012
Start date October 2007
Est. completion date March 2010

Study information

Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)South Africa: Medicines Control Council
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Intervention

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

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
GlaxoSmithKline African Organization for Research and Training in Cancer (AORTIC), University of Cape Town

Countries where clinical trial is conducted

Ghana,  Nigeria,  South Africa, 

Outcome

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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