Trial Information
Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand
Inclusion Criteria:
- A female aged 18 years and above at the time of cervical specimen collection, and
currently residing in New Zealand.
- Histological diagnoses of invasive cervical cancer stage IB or greater, within at
least the last 3 years.
- Written informed consent obtained from the subject/ next of kin/ Legally acceptable
representative.
- Availability of cervical specimen on which the diagnosis was made prior to any
chemotherapy or radiotherapy.
- The cervical specimen should be of appropriate size and with regular tissue
specimens.
- The cervical specimen should be adequately preserved.
- All links to the subject's identity should be removed from the paraffin block.
Exclusion Criteria:
Not Applicable.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Retrospective
Outcome Measure:
Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer
Outcome Time Frame:
At least the last 3 years from the time of study start
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
New Zealand: Medsafe
Study ID:
111050
NCT ID:
NCT01328028
Start Date:
April 2009
Completion Date:
April 2011
Related Keywords:
- Cervical Cancer
- Invasive cervical cancer
- Human papillomavirus
- Uterine Cervical Neoplasms