Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
Exec-PP-12
Universal Trial Number (UTN)
Trial acronym
Compass
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer of the Cervix 0 0
Cervical Intraepithelial Neoplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative CIN3+ (Cervical Intraepithelial Neoplasia Grade 3 or invasive cervical cancer) (ITT)
Timepoint [1] 0 0
Expected 5 year follow-up
Secondary outcome [1] 0 0
Cumulative CIN3+ in baseline screen-negative women (ITT)
Timepoint [1] 0 0
Expected 5 year follow-up
Secondary outcome [2] 0 0
Cumulative CIN3+ in baseline screen-negative women (per protocol)
Timepoint [2] 0 0
Expected 5 year follow-up
Secondary outcome [3] 0 0
Cumulative CIN2+ in baseline screen-negative women (ITT)
Timepoint [3] 0 0
Expected 5 year follow-up
Secondary outcome [4] 0 0
Baseline CIN2+ and CIN3+
Timepoint [4] 0 0
Following recruitment
Secondary outcome [5] 0 0
CIN2+ in women randomised to HPV testing at baseline with other oncogenic HPV
Timepoint [5] 0 0
Expected 12-24 month follow-up
Secondary outcome [6] 0 0
CIN2+ and CIN3+ in women who have an abnormal test result at baseline
Timepoint [6] 0 0
Expected 5 year follow-up
Secondary outcome [7] 0 0
CIN2+ and CIN3+ in women who were in follow-management for a previous abnormality at baseline
Timepoint [7] 0 0
Expected 5 year follow-up

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.
Minimum age
25 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
Accrual to date
Final
76181
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
VCS Foundation - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
VCS Foundation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Council New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02328872
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. doi: 10.1136/bmjopen-2017-016700corr1.
Joshy G, Thandrayen J, Koczwara B, Butow P, Laidsaar-Powell R, Rankin N, Canfell K, Stubbs J, Grogan P, Bailey L, Yazidjoglou A, Banks E. Disability, psychological distress and quality of life in relation to cancer diagnosis and cancer type: population-based Australian study of 22,505 cancer survivors and 244,000 people without cancer. BMC Med. 2020 Dec 1;18(1):372. doi: 10.1186/s12916-020-01830-4.
Sarich P, Canfell K, Egger S, Banks E, Joshy G, Grogan P, Weber MF. Alcohol consumption, drinking patterns and cancer incidence in an Australian cohort of 226,162 participants aged 45 years and over. Br J Cancer. 2021 Jan;124(2):513-523. doi: 10.1038/s41416-020-01101-2. Epub 2020 Oct 11.
Smith MA, Gertig D, Hall M, Simms K, Lew JB, Malloy M, Saville M, Canfell K. Transitioning from cytology-based screening to HPV-based screening at longer intervals: implications for resource use. BMC Health Serv Res. 2016 Apr 26;16:147. doi: 10.1186/s12913-016-1375-9.
Public notes

Contacts
Principal investigator
Name 0 0
Karen Canfell, BE, D.Phil.
Address 0 0
Cancer Council New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/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
Name 9 0
Marion Saville
Address 9 0
265 Faraday Street, Carlton, Victoria 3053
Country 9 0
Australia
Phone 9 0
+61 3 9250 0300
Fax 9 0
+61 3 9349 1949
Email 9 0
[email protected]
Contact person for public queries
Title 10 0
Miss
Name 10 0
Chloe Jennett
Address 10 0
153 Dowling Street, Woolloomooloo New South Wales 2011
Country 10 0
Phone 10 0
+61 2 9334 1418
Fax 10 0
+61 2 8302 3550
Email 10 0
[email protected]
Contact person for scientific queries
Title 11 0
Prof
Name 11 0
Karen Canfell
Address 11 0
153 Dowling Street, Woolloomooloo New South Wales 2011
Country 11 0
Australia
Phone 11 0
+612 9334 1900
Fax 11 0
+61 2 8302 3550
Email 11 0
[email protected]