Trial Review

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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 information initially 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
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
Secondary ID [1] 312648 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
confirmed malignancy 334641 0
Condition category
Condition code
Cancer 331203 331203 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
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.
Intervention code [1] 329232 0
Early Detection / Screening
Comparator / control treatment
Cohort 1 (see above) is the control group
Control group
Active

Outcomes
Primary outcome [1] 338997 0
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.
Timepoint [1] 338997 0
Urine samples were analysed on the same day as provided.
Secondary outcome [1] 438206 0
Nil
Timepoint [1] 438206 0
Nil

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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/02/2021
Date of last participant enrolment
Anticipated
Actual
29/11/2021
Date of last data collection
Anticipated
Actual
29/11/2021
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317079 0
Commercial sector/Industry
Name [1] 317079 0
ATH (Australia) Pty Ltd
Country [1] 317079 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ATH (Australia) Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319332 0
None
Name [1] 319332 0
Address [1] 319332 0
Country [1] 319332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315832 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 315832 0
https://bellberry.com.au/
Ethics committee country [1] 315832 0
Australia
Date submitted for ethics approval [1] 315832 0
03/08/2020
Approval date [1] 315832 0
26/10/2020
Ethics approval number [1] 315832 0
2020-08-745

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135938 0
A/Prof Toufic El-Khoury
Address 135938 0
Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
Country 135938 0
Australia
Phone 135938 0
+61410637174
Fax 135938 0
Email 135938 0
[email protected]
Contact person for public queries
Name 135939 0
Dr Nicolas De Luca
Address 135939 0
Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
Country 135939 0
Australia
Phone 135939 0
+61418160078
Fax 135939 0
Email 135939 0
[email protected]
Contact person for scientific queries
Name 135940 0
Dr Nicolas De Luca
Address 135940 0
Suite G12 Specialist Oncology Services, 9 Norbrik Drive bella Vista NSW 2153
Country 135940 0
Australia
Phone 135940 0
+61418160078
Fax 135940 0
Email 135940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Funder reportNo ATH MCH results2(Uploaded-01-08-2024-12-06-29)-MCH trial reportnew.pdf

Documents added automatically
No additional documents have been identified.