None listed
Conditions
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.
Interventions
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
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.
Sponsors
ATH (Australia) Pty Ltd
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed