Last updated: 11/03/2018 11:23:19

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

GSK study ID
111050
Clinicaltrials.gov ID
NCT01328028
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand
Trial description: The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer

Timeframe: At least the last 3 years from the time of study start

Secondary outcomes:

Occurrence of other high-risk HPV types in women with invasive cervical cancer

Timeframe: At least the last 3 years from the time of study start

Occurrence of HPV-16/ HPV-18 co-infection with other high-risk HPV types in women with invasive cervical cancer

Timeframe: At least the last 3 years from the time of study start

Occurrence of low-risk HPV types in women diagnosed with invasive cervical cancer

Timeframe: At least the last 3 years from the time of study start

Interventions:
  • Other: Testing of archived cervical cancer tissue samples
  • Other: Data collection
    • Enrollment:
    244
    Primary completion date:
    2011-13-04
    Observational study model:
    Case-Only
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Cervical Cancer
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to April 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • Not Applicable.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2011-13-04
    Actual study completion date
    2011-13-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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