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
ACTRN12610000702011
Ethics application status
Approved
Date submitted
23/08/2010
Date registered
25/08/2010
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of screening strategies for Cervical cancer prevention in Vanuatu
Scientific title
A comparative study of three screening strategies for determining cervical cancer risk amongst 30-50 year old Vanuatu women
Secondary ID [1] 252547 0
CICR-0602
The University of Queensland Centre for Immunology and Cancer Research
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer screening in healthy women 258028 0
Condition category
Condition code
Cancer 258194 258194 0 0
Cervical (cervix)
Public Health 258206 258206 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screening interventions - each done to each trial subject on one occasion only.
1) Visual Inspection of the cervix after application o f Acetic Acid (VIA) and after application of Lugol's Iodine (VILI),
2) Cervical Cytology on a Papanicolau smear sample ,
3) Human Papillomavirus testing (Performed on the Papanicolau smear sample)
Cervical Biopsy is the reference standard - taken from all subjects with any abnormality on any test, and on 10% of subjects with all tests normal.
Intervention code [1] 257069 0
Early detection / Screening
Comparator / control treatment
The comparator is a Cervical Biopsy
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259053 0
detection of Biopsy proven cervical Intraepithelial Neoplasia (CIN) 2/3
Timepoint [1] 259053 0
Within one month of presentation for screening
Secondary outcome [1] 265318 0
Relative efficacy of screening tests as assessed by their positive predicitve value, and negative predictive value, for biopsy proven CIN 2/3
Timepoint [1] 265318 0
On completion of data collection (12 months after study completion)

Eligibility
Key inclusion criteria
Asymptomatic Ni-Vanuatu women
Minimum age
30 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
past gynaecological surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2829 0
Vanuatu
State/province [1] 2829 0

Funding & Sponsors
Funding source category [1] 257513 0
Charities/Societies/Foundations
Name [1] 257513 0
Australians Working Abroad
Country [1] 257513 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland
4072
Country
Australia
Secondary sponsor category [1] 256746 0
None
Name [1] 256746 0
Address [1] 256746 0
Country [1] 256746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259540 0
The University of Queensland Human Ethics Experimentation Committee
Ethics committee address [1] 259540 0
The University of Queensland
St Lucia
Queensland 4072
Ethics committee country [1] 259540 0
Australia
Date submitted for ethics approval [1] 259540 0
Approval date [1] 259540 0
01/02/2006
Ethics approval number [1] 259540 0

Summary
Brief summary
To assess the relative effectiveness of three possible means of early detection of cervical cancer risk in a population of healthy women in vanuatu.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31558 0
Address 31558 0
Country 31558 0
Phone 31558 0
Fax 31558 0
Email 31558 0
Contact person for public queries
Name 14805 0
Ian Frazer
Address 14805 0
University of Queensland Diamantina Institute
Princess Alexandra Hospital
Woolloongabba 4102
Queensland
Country 14805 0
Australia
Phone 14805 0
+61 7 32405315
Fax 14805 0
Email 14805 0
[email protected]
Contact person for scientific queries
Name 5733 0
Ian Frazer
Address 5733 0
University of Queensland Diamantina Institute
Princess Alexandra Hospital
Woolloongabba 4102
Queensland
Country 5733 0
Australia
Phone 5733 0
+61 7 32405315
Fax 5733 0
Email 5733 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of a Cervical Cancer Screening Program Based on HPV Testing and LLETZ Excision in a Low Resource Setting2010https://doi.org/10.1371/journal.pone.0013266
N.B. These documents automatically identified may not have been verified by the study sponsor.