Trial Information
Human Papillomavirus (HPV) Type Distribution in Adult African Women Diagnosed With Invasive Cervical Cancer
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Outcome Measure:
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
Outcome Time Frame:
Average time frame: 6-12 months
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC)
Study ID:
109117
NCT ID:
NCT01207999
Start Date:
October 2007
Completion Date:
March 2010
Related Keywords:
- Infections, Papillomavirus
- Cervical Cancer
- Human papillomavirus
- Uterine Cervical Neoplasms