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
|
Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.
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
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.
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
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.