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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207999
• Other study ID #: 109117
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Infections, Papillomavirus
• Uterine Cervical Neoplasms

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