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

August 23, 2012 updated by: GlaxoSmithKline

Hospital-based Epidemiological Study on the Distribution of Human Papillomavirus (HPV) Types in Adult Women Diagnosed With Invasive Cervical Cancer (ICC) in New Zealand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged >= 18 years at the time that the cervical specimen was taken, and diagnosed with invasive cervical cancer stage IB or greater

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Subjects diagnosed with invasive cervical cancer
Other: Testing of archived cervical cancer tissue samples
Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.
Other: Data collection
Log sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of HPV-16 and HPV-18 in women with invasive cervical cancer
Time Frame: At least the last 3 years from the time of study start
At least the last 3 years from the time of study start

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of other high-risk HPV types in women with invasive cervical cancer
Time Frame: At least the last 3 years from the time of study start
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
Time Frame: At least the last 3 years from the time of study start
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
Time Frame: At least the last 3 years from the time of study start
At least the last 3 years from the time of study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2012

Last Update Submitted That Met QC Criteria

August 23, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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