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Trial registered on ANZCTR
Registration number
ACTRN12624001029583
Ethics application status
Approved
Date submitted
1/08/2024
Date registered
26/08/2024
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Date results provided
26/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Novel Urine Test to Determine Abnormal Cell Metabolism in adults 40 - 80 years old
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Scientific title
A Double Blind Study to Evaluate a Novel Urine Metabolic Test (MyCellHealth) to Determine Possible Abnormal Cell Metabolism in adults 40 - 80 years old
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Secondary ID [1]
312648
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None
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Universal Trial Number (UTN)
None
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Trial acronym
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
confirmed malignancy
334641
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Condition category
Condition code
Cancer
331203
331203
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0
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Any cancer
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
coh1 - males and females age 40-80. Well patients in whom there is no known cancer nor cancer suspected.
Cohort 2 - patients age 40-80 with a confirmed malignancy diagnosis.
patients were asked to provide an early morning urine sample which was tested.
Patients are observed only at the time of regular consultatation.
Eligible participants were asked to provide a first void urine sample.
The urine samples were tested using a novel Urine Metabolic Test, called MyCellHealth (MCH).
The MCH test is a simple, inexpensive, non-invasive, point of care, medical device that may be a useful indicator of early cancer cell turnover. Cancers have a higher cell turnover and produce greater amounts of amino acids. Some of these are excreted in urine at higher than normal amounts, eg Tyrosine and L-Dopa. The patented MCH test produces a reaction to above average amino acid quantities, giving a contrasting reddish colour, thus indicating high amino acid turnover and possible cancer.
Therefore, it can be used as an indicator of cancer / abnormal cell growth.or if negative exclude cancer / abnormal cell growth.
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Intervention code [1]
329232
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Early Detection / Screening
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Comparator / control treatment
Cohort 1 (see above) is the control group
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome of the study is to evaluate the performance of the MCH Test Kit in detecting abnormal cell metabolism in urine samples from known cancer patients, compared to samples from non-cancer patients.
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Assessment method [1]
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Eligible participants were provided a urine collection pot with a label detailing their unique study ID at the end of their clinic visit to provide a sample of first void urine. Women of childbearing potential were asked to complete a urine pregnancy test and if positive, were deemed a screen fail and exited from the study. Participants were encouraged to provide a first void, midstream
sample of 40 to 50ml of urine into the pot the following morning. After the participant had collected a sample of their urine, a pathology courier collected the sample on the same day to take to the lab for testing. The Core Lab analysed the results using the MCH Test Kit according to the Instructions for use, using the Pantone colour chart provided. A positive or negative result was recorded in the Electronic Data Caption system.
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Timepoint [1]
338997
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Urine samples were analysed on the same day as provided.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
438206
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Nil
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Eligibility
Key inclusion criteria
Cohort One.
1. Attending one of the Specialist clinics involved in the study.
2. Male or female aged between 40 and 80 inclusive.
3. Otherwise healthy and not known to have malignancy or following appropriate testing to have benign disease as adjudicated by the participant’s doctor.
Cohort Two:
1. Attending one of the Specialist clinics involved in the study.
2. Male or female aged between 40 and 80 inclusive.
3. Known malignancy determined by the participant’s study doctor by way of routine diagnosis including, but not limited to physical examination, biopsy, pathology and/or imaging.
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
To be eligible to participate in the study, participants from all cohorts had to meet none of the following:
1. Terminally ill stage or palliative
2. Diagnosed with cancer and currently undergoing chemotherapy, radiation or surgery (not including biopsy)
3. Currently pregnant, menstruating and or breast feeding
4. Currently taking sulphur containing medications
5. Diagnosed with lupus
6. Prone to UTIs or have had a suspected or diagnosed UTI in the past 7 days.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
This is a study intended to assess the MCH Test Kit’s ability to detect abnormal cell metabolism. There is currently no known abnormal cell screening standard to compare the results of the MCH Test Kit against. The general analytical approach to the primary endpoint will be descriptive in nature and will include frequency counts and percentages per category, giving sensitivity, specificity and accuracy.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
23/02/2021
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Date of last participant enrolment
Anticipated
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Actual
29/11/2021
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Date of last data collection
Anticipated
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Actual
29/11/2021
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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ATH (Australia) Pty Ltd
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Address [1]
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Country [1]
317079
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
ATH (Australia) Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319332
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Address [1]
319332
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Country [1]
319332
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee F
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
315832
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Australia
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Date submitted for ethics approval [1]
315832
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03/08/2020
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Approval date [1]
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26/10/2020
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Ethics approval number [1]
315832
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2020-08-745
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Summary
Brief summary
The objective of the study is to evaluate the performance of the MyCellHealth (MCH) Test Kit in detecting abnormal cell metabolism in urine samples from known cancer patients, compared to samples from non-cancer patients. Who is it for? You may be eligible for this study if you are a male or female aged between 40 to 80 years old, attending one of the specialist clinics involved in this study. You will be recruited into cohort one if you are otherwise healthy and not known to have malignancy or following appropriate testing to have benign disease as adjudicated by the participant’s doctor. You will be recruited into cohort 2 if you have any known malignancy determined by the participant’s study doctor by way of routine diagnosis including, but not limited to physical examination, biopsy, pathology and/or imaging. Eligible participants were provided a urine collection pot with a label detailing their unique study ID at the end of their clinic visit to provide a sample of first void urine. Women of childbearing potential were asked to complete a urine pregnancy test and if positive, were deemed a screen fail and exited from the study. Participants were encouraged to provide a first void, midstream sample of 40 to 50ml of urine into the pot the following morning. After the participant had collected a sample of their urine, a pathology courier collected the sample on the same day to take to the lab for testing. The Core Lab analysed the results using the MCH Test Kit according to the Instructions for use, using the Pantone colour chart provided. A positive or negative result was recorded in the Electronic Data Caption system. It is hoped that findings from this study will help detect potential cancer early and improve cancer outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Toufic El-Khoury
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Address
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Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
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Country
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Australia
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Phone
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+61410637174
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Nicolas De Luca
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Address
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Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
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Country
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Australia
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Phone
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+61418160078
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Nicolas De Luca
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Address
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Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
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Country
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Australia
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Phone
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+61418160078
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Fax
135940
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Email
135940
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No - IPD will not be available
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Funder report
No
ATH MCH results2(Uploaded-01-08-2024-12-06-29)-MCH trial reportnew.pdf
Documents added automatically
No additional documents have been identified.
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