Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001414202
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
24/08/2018
Date last updated
11/02/2021
Date data sharing statement initially provided
12/08/2019
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
HPV types in young New Zealand women with high grade cervical cell abnormalities
Scientific title
High Risk HPV genotyping in young women under 25 in New Zealand with high grade histology in the post-HPV vaccination era
Secondary ID [1] 295824 0
None
Universal Trial Number (UTN)
U1111-1219-0464
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cell abnormality 309264 0
Condition category
Condition code
Cancer 308136 308136 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All women aged 20-24 years attending colposcopy following abnormal screening cytology in participating centres will be invited to participate in the study. Consenting women will have a cytology sample taken from the cervix as part of their colposcopy. High risk HPV testing and extended genotyping will be performed by the BD viper assay performed by Canterbury Health Laboratory or partial genotyping (HPV 16, HPV 18, other high risk HPV, or high risk HPV not detected) using the HPV assay routinely used by that laboratory. This will be a one-off test and there will be no further follow-up specific to the study.
Intervention code [1] 312156 0
Not applicable
Comparator / control treatment
The HPV type prevalence in women with high grade cervical abnormalities (CIN2 or 3) will be compared with historical data (August 2009 to February 2011) (Simonella LM, Lewis H, Smith M, Neal H, Bromhead C, Canfell K. Type-specific oncogenic human papillomavirus infection in high grade cervical disease in New Zealand. BMC Infect Dis 2013;13:114).
Control group
Historical

Outcomes
Primary outcome [1] 307115 0
The prevalence of high risk vaccine-type human papillomavirus genotypes (either HPV 16 or 18 or both) in young women (aged 20-24 years) with high grade histology (e.g., CIN2 or CIN3).
Timepoint [1] 307115 0
HPV genotype analysis for each participant will be undertaken on the cytology taken at the initial colposcopic assessment. HPV genotype prevalence will be assessed once all participants have been recruited - approximately 12 months after first enrolment.
Secondary outcome [1] 350734 0
HPV vaccination status as assessed by data-linkage to the National Immunisation Register.
Timepoint [1] 350734 0
HPV vaccination status for each participant will be requested following their initial colposcopic assessment. Analysis of the overall group will be assessed once all participants have been recruited - approximately 12 months after first enrolment.
Secondary outcome [2] 350735 0
The prevalence of high risk vaccine-type human papillomavirus genotypes (either HPV 16 or 18 or both) compared with (1) other high risk non-vaccine genotypes and (2) co-infection with vaccine-type HPV genotypes and high risk non-vaccine genotypes, in young women (aged 20-24 years) with LOW grade histology (e.g., CIN1)..
Timepoint [2] 350735 0
HPV genotype analysis for each participant will be undertaken on the cytology taken at the initial colposcopic assessment. HPV genotype prevalence will be assessed once all participants have been recruited - approximately 12 months after first enrolment.

Eligibility
Key inclusion criteria
Women aged 20-24 years.
Referred to colposcopy (at a participating centre) with an abnormal smear.
Minimum age
20 Years
Maximum age
24 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The analysis of data will be largely descriptive. A two-proportion z-test will be used to determine whether there is a difference in the proportion of women with HPV 16 or 18 positive cytology in this sample compared with historical data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
26/09/2018
Date of last participant enrolment
Anticipated
30/09/2020
Actual
27/08/2020
Date of last data collection
Anticipated
30/09/2020
Actual
10/09/2020
Sample size
Target
350
Accrual to date
Final
154
Recruitment outside Australia
Country [1] 20782 0
New Zealand
State/province [1] 20782 0

Funding & Sponsors
Funding source category [1] 300419 0
Charities/Societies/Foundations
Name [1] 300419 0
Australian Society for Colposcopy and Cervical Pathology
Country [1] 300419 0
Australia
Funding source category [2] 300421 0
Commercial sector/Industry
Name [2] 300421 0
BD
Country [2] 300421 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Private Bag 4711
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 299881 0
None
Name [1] 299881 0
Address [1] 299881 0
Country [1] 299881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301223 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301223 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 301223 0
New Zealand
Date submitted for ethics approval [1] 301223 0
01/02/2018
Approval date [1] 301223 0
12/03/2018
Ethics approval number [1] 301223 0
18/NTA/13

Summary
Brief summary
Most cervical cell abnormalities are caused by infection with high risk types of human papillomavirus (HPV). In 2008, a national HPV vaccination programme was commenced in New Zealand. The vaccine protects women from infection with HPV 16 and 18, the HPV types associated with the majority of cervical cell abnormalities (precancers) and cervical cancer. A previous study found that at that time (2009-2011), approximately 70% of women aged under 29 with high grade cervical cell abnormalities were infected with HPV 16 or 18. Our study aims to determine the HPV types carried by young women (aged 20-24 years) with abnormal cervical cells in New Zealand currently and to compare this with previous data. We hypothesize that young women with high grade disease will have HPV 16 or 18 in the minority of cases and that in both vaccinated and non-vaccinated women this will be less than that seen in the historical study.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 86286 0
A/Prof Peter Sykes
Address 86286 0
Dept Obstetrics & Gynaecology
University of Otago, Christchurch
Level 3, Christchurch Women’s Hospital
2 Riccarton Ave
Christchurch 8011
Country 86286 0
New Zealand
Phone 86286 0
+61 3 364 4647
Fax 86286 0
+61 3 364 4634
Email 86286 0
[email protected]
Contact person for public queries
Name 86287 0
A/Prof Peter Sykes
Address 86287 0
Dept Obstetrics & Gynaecology
University of Otago, Christchurch
Level 3, Christchurch Women’s Hospital
2 Riccarton Ave
Christchurch 8011
Country 86287 0
New Zealand
Phone 86287 0
+61 3 364 4647
Fax 86287 0
+61 3 364 4634
Email 86287 0
[email protected]
Contact person for scientific queries
Name 86288 0
A/Prof Peter Sykes
Address 86288 0
Dept Obstetrics & Gynaecology
University of Otago, Christchurch
Level 3, Christchurch Women’s Hospital
2 Riccarton Ave
Christchurch 8011
Country 86288 0
New Zealand
Phone 86288 0
+61 3 364 4647
Fax 86288 0
+61 3 364 4634
Email 86288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3936Study protocol  [email protected]
3937Informed consent form  [email protected]
3938Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.