Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02328872
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT02328872
Ethics application status
Date submitted
18/12/2014
Date registered
31/12/2014
Date last updated
14/02/2024
Titles & IDs
Public title
Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia
Query!
Scientific title
Compass - Randomized Controlled Trial of 5-yearly Cervical Screening With Primary HPV Testing Versus Cervical Screening With 2.5-yearly Liquid Based Cytology Testing, in HPV-Unvaccinated and HPV-Vaccinated Women in Australia
Query!
Secondary ID [1]
0
0
Exec-PP-12
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Compass
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cancer of the Cervix
0
0
Query!
Cervical Intraepithelial Neoplasia
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Cancer
0
0
0
0
Query!
Womb (Uterine or endometrial cancer)
Query!
Cancer
0
0
0
0
Query!
Cervical (cervix)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Molecular testing for HPV
Treatment: Devices - Liquid Based Cytology
Experimental: Intervention (HPV Arm) - Molecular testing for HPV with partial genotyping for types 16/18, with referral of the HPV16/18-positive group for diagnostic evaluation, and secondary randomisation of women testing positive for other oncogenic HPV infection (not 16/18), to either image-read cytology screening or dual-stained (DS) cytology testing with p16/Ki67 - the "HPV arm". Screening performed 5 yearly.
Active Comparator: Control (LBC Arm) - Image-read liquid based cytology (LBC) screening with reflex HPV triage testing for low grade smears, the "LBC arm." Screening performed 2.5 yearly.
Treatment: Devices: Molecular testing for HPV
Molecular testing for HPV with a test allowing partial genotyping for separate identification of types 16/18 from cervical samples. The technology used in this trial will be approved by the Therapeutic Goods Administration (TGA) Australia. It will identify the major HPV oncogenic genotypes in a pool and separately identify HPV 16 and 18. It will also satisfy performance criteria for relative sensitivity and specificity compared to Hybrid Capture 2 (HC2 ) as articulated by Meijer et al, 2009, Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.
Treatment: Devices: Liquid Based Cytology
The liquid based cytology (LBC) used in this trial will be will be approved by the Therapeutic Goods Administration (TGA) Australia for LBC and appropriately validated and (TGA approved) to perform human papillomavirus testing from a cytology sample.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Cumulative CIN3+ (Cervical Intraepithelial Neoplasia Grade 3 or invasive cervical cancer) (ITT)
Query!
Assessment method [1]
0
0
The primary outcome will be cumulative CIN3+ at 5 years following a 5 year HPV exit testing round in both arms, in women randomised to the HPV arm vs. women randomised to the LBC arm, adjusted for censoring after CIN2+ treatment. For the primary outcome, intention to treat analysis will be performed with closed loop testing for non-inferiority and superiority if non-inferiority is declared. Assuming a total average CIN3+ rate in the LBC arm (across unvaccinated and vaccinated women) of 0.94%, and an absolute non-inferiority margin of 0.22%, the trial will have 78% power with 97.5% confidence to detect non-inferiority for the HPV arm, allowing for a 15% non-compliance rate.
Query!
Timepoint [1]
0
0
Expected 5 year follow-up
Query!
Secondary outcome [1]
0
0
Cumulative CIN3+ in baseline screen-negative women (ITT)
Query!
Assessment method [1]
0
0
Cumulative CIN3+ in women presenting for routine screening randomised to the HPV arm who were HPV-negative at baseline, vs. CIN3+ in those randomised to the LBC arm and who were LBC-negative at baseline, adjusted for censoring after CIN2+ treatment and stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980). Intention to treat analysis will be performed with closed loop testing for non-inferiority and superiority if non-inferiority is declared.
Query!
Timepoint [1]
0
0
Expected 5 year follow-up
Query!
Secondary outcome [2]
0
0
Cumulative CIN3+ in baseline screen-negative women (per protocol)
Query!
Assessment method [2]
0
0
Cumulative CIN3+ in women presenting for routine screening randomised to the HPV arm who were HPV-negative at baseline, vs. CIN3+ in those randomised to the LBC arm and who were LBC-negative at baseline and at 2.5 years, adjusted for censoring after CIN2+ treatment and stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980). Per-protocol analysis will be performed in women screened and followed up within a defined tolerance period according to protocol recommendations.
Query!
Timepoint [2]
0
0
Expected 5 year follow-up
Query!
Secondary outcome [3]
0
0
Cumulative CIN2+ in baseline screen-negative women (ITT)
Query!
Assessment method [3]
0
0
Cumulative CIN2+ in women randomised to the HPV arm who were HPV-negative at baseline, vs. CIN2+ in women who were randomised to the LBC arm and were LBC-negative at baseline, adjusted for censoring after CIN2+ treatment and stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980).
Query!
Timepoint [3]
0
0
Expected 5 year follow-up
Query!
Secondary outcome [4]
0
0
Baseline CIN2+ and CIN3+
Query!
Assessment method [4]
0
0
Cross-sectional outcomes for CIN 2+ and CIN3+ detection in each arm, stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980).
Query!
Timepoint [4]
0
0
Following recruitment
Query!
Secondary outcome [5]
0
0
CIN2+ in women randomised to HPV testing at baseline with other oncogenic HPV
Query!
Assessment method [5]
0
0
CIN2+ in women randomised to HPV testing at baseline who have other HPV (not 16/18), stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980).
Query!
Timepoint [5]
0
0
Expected 12-24 month follow-up
Query!
Secondary outcome [6]
0
0
CIN2+ and CIN3+ in women who have an abnormal test result at baseline
Query!
Assessment method [6]
0
0
CIN2+ and CIN3+ in women who have an abnormal test result at baseline, adjusted for censoring after CIN2+ treatment and stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980).
Query!
Timepoint [6]
0
0
Expected 5 year follow-up
Query!
Secondary outcome [7]
0
0
CIN2+ and CIN3+ in women who were in follow-management for a previous abnormality at baseline
Query!
Assessment method [7]
0
0
CIN2+ and CIN3+ in women who were in follow-management for a previous abnormality at baseline, adjusted for censoring after CIN2+ treatment and stratified by recruitment group (date of birth >=July 1st 1980 and <1st July 1980).
Query!
Timepoint [7]
0
0
Expected 5 year follow-up
Query!
Eligibility
Key inclusion criteria
- Australian residents with a cervix, aged 25-69 years who are attending for routine
cervical screening. (Note: since April 2016 recruitment has been confined to the
younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born
on or after 1st July 1980, as the recruitment target of the older cohort was met).
- Participants may have been previously enrolled in the Compass Pilot but must have been
discharged to routine screening. Women may also be in follow-up management for a
previous abnormality or unsatisfactory cytology.
Query!
Minimum age
25
Years
Query!
Query!
Maximum age
69
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- Previous total hysterectomy (uterus and cervix).
- The presence of symptoms or signs for which cervical cancer must be excluded.
- Currently undergoing treatment for cervical cancer.
- Currently enrolled in the Compass Pilot Study.
Query!
Study design
Purpose of the study
Screening
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
76181
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
VCS Foundation - Carlton
Query!
Recruitment postcode(s) [1]
0
0
3053 - Carlton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
VCS Foundation
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Cancer Council New South Wales
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening
in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial
will involve recruiting 76,300 women from primary health clinics. Women aged 25-69, attending
for cervical screening or for routine follow-up will be invited to participate in the 2-arm
trial. A liquid-based cytology (LBC) sample will be taken from consenting women and sent to
VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and HPV
arms using randomisation with the minimisation procedure, with stratification by birth cohort
according to whether offered HPV vaccination in Australia's national publicly-funded HPV
vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC (active
control) arm, women will undergo 2.5 yearly image read cytology screening with reflex HPV
triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5
yearly HPV screening with partial genotyping enabling separate identification of HPV16 and
HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of
"intermediate risk" women testing positive for oncogenic HPV (but not HPV 16 or 18) to either
image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory
reports issued to practitioners will specify the recommended management for women, according
to study arm and test results.Participating women will be flagged and clinical outcomes will
be tracked via the Compass Register. Data linkage between the Compass Register and HPV
vaccination records held on the Australian Immunisation Register will be performed in order
to integrate vaccination and screening histories for trial participants. Participants will be
actively followed for an anticipated 5 years from the time of recruitment and the primary
outcome is based on the total cumulative detection of CIN3+ after exit testing at 5 years.
The anticipated study completion date of March 2027 takes into consideration the final
migration of participants to the National Cancer Screening Register and allows for two years
to follow-up any intermediate risk results occurring in the last of the recruited trial
participants.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02328872
Query!
Trial related presentations / publications
Canfell K, Saville M, Caruana M, Gebski V, Darlington-Brown J, Brotherton J, Heley S, Castle PE. Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25-69 years living in Australia. BMJ Open. 2018 Jan 26;8(1):e016700. doi: 10.1136/bmjopen-2017-016700. Erratum In: BMJ Open. 2018 Mar 8;8(3):e016700corr1.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Karen Canfell, BE, D.Phil.
Query!
Address
0
0
Cancer Council New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02328872
Additional trial details provided through ANZCTR
Accrual to date
74418
Recruiting in Australia
Recruitment state(s)
SA,VIC
Funding & Sponsors
Primary sponsor
Charities/Societies/Foundations
Primary sponsor name
The Victorian Cytology Service Ltd
Primary sponsor address
265 Faraday Street, Carlton, Victoria 3053, Australia
Primary sponsor country
Australia
Other collaborator category [1]
1
Charities/Societies/Foundations
Name [1]
1
Cancer Council New South Wales
Address [1]
1
153 Dowling Street, Woolloomooloo New South Wales 2011
Country [1]
1
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
2
Bellberry Human Research Ethics Committee B
Address [1]
2
129 Glen Osmond Road Eastwood South Australia 5063
Country [1]
2
Australia
Date submitted for ethics approval [1]
2
19/11/2014
Approval date [1]
2
19/12/2014
Ethics approval number [1]
2
2014-11-592
Public notes
To find a participating practice please visit: http://www.compasstrial.org.au/for-women/trial-registration
Contacts
Principal investigator
Title
9
0
A/Prof
Query!
Name
9
0
Marion Saville
Query!
Address
9
0
265 Faraday Street, Carlton, Victoria 3053
Query!
Country
9
0
Australia
Query!
Phone
9
0
+61 3 9250 0300
Query!
Fax
9
0
+61 3 9349 1949
Query!
Email
9
0
[email protected]
Query!
Contact person for public queries
Title
10
0
Miss
Query!
Name
10
0
Chloe Jennett
Query!
Address
10
0
153 Dowling Street, Woolloomooloo New South Wales 2011
Query!
Country
10
0
Query!
Phone
10
0
+61 2 9334 1418
Query!
Fax
10
0
+61 2 8302 3550
Query!
Email
10
0
[email protected]
Query!
Contact person for scientific queries
Title
11
0
Prof
Query!
Name
11
0
Karen Canfell
Query!
Address
11
0
153 Dowling Street, Woolloomooloo New South Wales 2011
Query!
Country
11
0
Australia
Query!
Phone
11
0
+612 9334 1900
Query!
Fax
11
0
+61 2 8302 3550
Query!
Email
11
0
[email protected]
Query!
Download to PDF