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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

ACTRN12625000445471

Ethics application status

Not required

Date submitted

16/08/2024

Date registered

13/05/2025

Date last updated

13/05/2025

Date data sharing statement initially provided

13/05/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessing the validity of a non invasive in vitro tumor detection test

Scientific title

Assessing the validity of a non invasive in vitro tumor detection test: comparing healthy volunteers to suspected tumour patients

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Any cancer

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

In the testing by using urine or saliva, participants will be those diagnosed with cancer or undergoing treatment. Urine or saliva can collected by either the participants themselves or professionals, depending on the participants' own decisions. Participants can use this kit regardless of their involvement in this study, and no other samples required.

In the testing by using tissue samples, tissue samples will be cancer samples and sourced from existing biobanks. This testing will occur prior to enrolment of participants.

Above testings are to primarily confirm the kit's accuracy, sensitivity, repeatability, and manufacturing validation.

Administration.
Depending on various countries' regulations, the kit may be for sale either freely or by prescription. Since its form and instruction are totally like the on-market pregnant test kit, no special administration is required.
Detected once only.
Observative in 10 minutes depending on what samples used.
Direct observation by the participant themself,.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Healthy samples will come from a biobank to confirm the kit's accuracy, so no healthy volunteers will be involved in this study.

Samples include: Cerebrospinal fluid, Pleural fluid, Peritoneal fluids, Bile, Uterine lavage, Blood, Tissue homogenate, etc.

Biobanks that will be used:
- Shanghai Biobank
- Auckland Regional Biobank
- UK Biobank
- Mayo Clinic Biobank

Control group

Active

Outcomes

Primary outcome [1]

Both accuracy and sensitivity will be assessed together as a composite primary outcome.

Timepoint [1]

Up to 10 minutes after the sample is placed into the kit's testing well.

Secondary outcome [1]

Detection of all cancers using urine will be assessed as a composite secondary outcome.

Timepoint [1]

Up to 10 minutes after the sample is placed into the kit's testing well.

Secondary outcome [2]

Detection of all cancers using all available body liquids will be assessed as a composite secondary outcome.

Timepoint [2]

Up to 10 minutes after the sample is placed into the kit's testing well.

Secondary outcome [3]

Detection of all cancers using isolated tissue homogenate will be assessed as a composite secondary outcome.

Timepoint [3]

Up to 10 minutes after the sample is placed into the kit's testing well.

Eligibility

Key inclusion criteria

Cancer samples
Will be sourced from the UK Biobank, Mayo Clinic Biobank, Auckland Regional Biobank and Shanghai Biobank, which are already pathologically identified and exanimated by the biobanks.

Healthy samples
Will be sourced from the UK Biobank, Mayo Clinic Biobank, Auckland Regional Biobank and Shanghai Biobank, which are already pathologically identified and exanimated by the biobanks.

UK Biobank is a large-scale biomedical database and research resource containing de-identified genetic, lifestyle and health information and biological samples from half a million UK participants. https://www.ukbiobank.ac.uk/.

Mayo Clinic Biobank is a biorepository that collects blood, tissue and health data from Mayo Clinic patients and volunteers. It supports research on how genes and other factors influence health and wellness. https://www.mayo.edu/research/centers-programs/mayo-clinic-biobank/overview.

Auckland Regional Biobank is a secure facility that hosts a collection of donated patient tissue samples as well as relevant clinical information regarding these samples to support ethically approved research. https://www.biobank.ac.nz/,

Shanghai Biobank is the biggest biobank in China with 15 million human samples (no web).

As the kit is designed for either self detection, cancer screening, and cancer pathology substitution, no criteria required for those tests using urine or saliva by participants themselves.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

under 18 years.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2025

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

3000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

Armenia

State/province [2]

Country [3]

China

State/province [3]

Country [4]

Philippines

State/province [4]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gamay Commercials Ltd

Address [1]

Country [1]

China

Primary sponsor type

Commercial sector/Industry

Name

Health New Zealand Ltd

Address

Country

New Zealand

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Gamay Commercials Ltd

Address [1]

Country [1]

China

Ethics approval

Ethics application status

Not required

Summary

Brief summary

This study aims to assess the sensitivity and accuracy of a novel in vitro testing kit for the detection of tumour biomarkers from human tissue samples.

Who is it for?
You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with any cancer type (including early or advanced stage cancers).

Additionally, samples from adults who have never been diagnosed with cancer will be collected from the following biobanks:
- Shanghai Biobank
- Auckland Regional Biobank
- UK Biobank
- Mayo Clinic Biobank

Study details
Participants who choose to participate in this study will be asked to provide up to 3 blood samples (no more than 1 ml per sample), 3 saliva samples and 3 urine samples for testing, or other tissue samples collected in medication organization (no more than 1g per sample). Participants may be contacted up to 2 times over a 6 week period to attend a clinic to provide these samples, no further assessments will be required.

For data collected from biobanks from participants without cancer, these will also be tested using the novel in vitro testing kit for the detection of tumour biomarkers.

It is hoped this research will demonstrate that a novel at home testing kit is able to accurately detect tumour biomarkers in urine samples for early cancer detection. If this kit is found to be accurate, the rate of early cancer detection may increase and a greater number of future cancer patients may be able to access treatment earlier than anticipated. Also it is hoped this research will demonstrate that a novel testing kit is able to be used as the common pathology substitution at a much lower cost, easier operating and faster resulting.

Trial website

Trial related presentations / publications

Public notes

Detection conducted by using urine or saliva is a self-managed at-home detection, no ethics required.

Contacts

Principal investigator

Name

Dr Robert Peng

Address

Health New Zealand Ltd, Auckland, PO Box 217116

Country

New Zealand

Phone

+64 204400999

Fax

[email protected]

Contact person for public queries

Name

Robert Peng

Address

Health New Zealand Ltd, Auckland, PO Box 217116

Country

New Zealand

Phone

+64 204400999

Fax

[email protected]

Contact person for scientific queries

Name

Robert Peng

Address

Health New Zealand Ltd, Auckland, PO Box 217116

Country

New Zealand

Phone

+64 20 4400999

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically