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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000445471
Enrollment
3000
Registered
2025-05-13
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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,.

Sponsors

Health New Zealand Ltd
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

under 18 years.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026