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
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] 312770 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 334810 0
Condition category
Condition code
Cancer 331371 331371 0 0
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] 329301 0
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] 339131 0
Both accuracy and sensitivity will be assessed together as a composite primary outcome.
Timepoint [1] 339131 0
Up to 10 minutes after the sample is placed into the kit's testing well.
Secondary outcome [1] 446395 0
Detection of all cancers using all available body liquids will be assessed as a composite secondary outcome.
Timepoint [1] 446395 0
Up to 10 minutes after the sample is placed into the kit's testing well.
Secondary outcome [2] 446396 0
Detection of all cancers using isolated tissue homogenate will be assessed as a composite secondary outcome.
Timepoint [2] 446396 0
Up to 10 minutes after the sample is placed into the kit's testing well.
Secondary outcome [3] 438672 0
Detection of all cancers using urine will be assessed as a composite secondary outcome.
Timepoint [3] 438672 0
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] 26516 0
China
State/province [1] 26516 0
Country [2] 26514 0
New Zealand
State/province [2] 26514 0
Country [3] 26515 0
Armenia
State/province [3] 26515 0
Country [4] 26517 0
Philippines
State/province [4] 26517 0

Funding & Sponsors
Funding source category [1] 317202 0
Commercial sector/Industry
Name [1] 317202 0
Gamay Commercials Ltd
Country [1] 317202 0
China
Primary sponsor type
Commercial sector/Industry
Name
Health New Zealand Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 319471 0
Commercial sector/Industry
Name [1] 319471 0
Gamay Commercials Ltd
Address [1] 319471 0
Country [1] 319471 0
China

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136290 0
Dr Robert Peng
Address 136290 0
Health New Zealand Ltd, Auckland, PO Box 217116
Country 136290 0
New Zealand
Phone 136290 0
+64 204400999
Fax 136290 0
Email 136290 0
[email protected]
Contact person for public queries
Name 136291 0
Robert Peng
Address 136291 0
Health New Zealand Ltd, Auckland, PO Box 217116
Country 136291 0
New Zealand
Phone 136291 0
+64 204400999
Fax 136291 0
Email 136291 0
[email protected]
Contact person for scientific queries
Name 136292 0
Robert Peng
Address 136292 0
Health New Zealand Ltd, Auckland, PO Box 217116
Country 136292 0
New Zealand
Phone 136292 0
+64 20 4400999
Fax 136292 0
Email 136292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.