Bowel Cancer Clinical Trial
AIM: Working alongside a full scientific and clinical team it is K9 Medical Detection New Zealand's aim to create a simple diagnostic urine test as a value-added tool in the fight against bowel cancer, therefore offering an alternative to current faecal testing in New Zealand.
BACKGROUND: Bowel cancer is the most commonly diagnosed cancer here in New Zealand with approximately 3200 people diagnosed each year and 1200 dying from this disease. Up to 90% of people can be saved if the cancer is detected early enough.
FREE NATIONAL BOWEL SCREENING PROGRAMME
Currently there is a government-funded National Bowel Screening Programme available for 60-74 year olds but is only available in 14 out of 20 District Health Boards (DHB’s). There are current delays due to capacity issues and DHB’s readiness to cope.
This Bowel Screening Programme is expected to be rolled out progressively throughout New Zealand across all 20 DHB’s before the end of 2021. Delayed due to the COVID-19 pandemic.
Once fully implemented, the National Bowel Screening Programme is expected to detect between 500-700 bowel cancers a year. This age group only accounts for approximately 36% of all bowel cancers registered in New Zealand annually. (Ministry of Health).
Participants are sent a home bowel screening kit which is used in the privacy of their own home.
A faecal sample is required to be collected by the participant and sent within a certain time frame in a prepaid envelope for testing. If the sample is heat damaged or received outside of the specified time frame, the sample is destroyed, and participants are required to do the test again.
This test is used to detect blood in patient’s faecal sample which would indicate bleeding polyps which can turn in to bowel cancer. Unfortunately, these tests can also pick up bleeding in the bowel which can indicate internal issues such as inflammatory bowel conditions (Crohn’s Disease, Ulcerative Colitis or Coeliac Disease), haemorrhoids or patients may have even eaten something that has scratched them internally on the way down.
New Zealand has the third-worst rate of inflammatory bowel disease in the world and it is growing at an alarming rate. A new study has found that as many as 70,000 Kiwis are currently living with the disease, and symptoms can mirror a number of bowel cancer ones which can include abdominal pain, diarrhoea, rectal bleeding and weight loss.
The NZ National screening unit expects 7% of all home screening kits sent out to those between the ages of 60-74 to return a positive result for blood.
IBD conditions including Crohn’s Disease and Ulcerative Colitis is often picked up through these current bowel screening kits.
Any sample that detects blood requires the patient to have a follow up colonoscopy where a camera is used to detect any polyps or cancers within the bowel. This can be very costly and invasive.
If we can find those patients who are more likely to have bowel cancer through early detection from K9 Medical Detection, we can push them to the front of the colonoscopy queue and save more lives.
LOW PARTICIPATION RATES IN NZ
The government's national bowel screening programme has been in operation since its rollout in 2017. The National screening unit expects a low 62% participation rate overall.
Figures obtained from the Ministry of Health’s National Screening Unit, Screening Insights and Analytics Department shows lower than expected participation rates in some DHB’s of only 52% (Counties Manukau DHB - 31st July 2019).
It has been reported that only 50% of Maori and Pasifika communities participate overall and are the group most likely to be diagnosed with bowel cancer before the age of 60.
K9 Medical Detection NZ has strict protocols and robust methodologies for all medical detection trials. Research trials are led by Professor Sarah Young, in conjunction with Associate Professor Michelle McConnell as Research Project Manager; Biostatistician Professor Robin Turner; K9MD Director Pauline Blomfield and Bowel Cancer New Zealand. K9 Medical Detection NZ have clinical facilities in Dunedin including three laboratories for the safe handling and storing of all medical samples.
In January 2020 K9MD German shepherd Levi commenced training to detect bowel cancer. In December 2020 The University of Otago issued a press release on the results of year one.
K9MD Levi has completed a blind randomised validation testing 400 samples over 5 consecutive days for the "Proof of Concept" stage. The results were world leading with a success of 98.4% sensitivity (correctly identifying those with a disease) and 100% success specificity (correctly identifying those without a disease).
K9MD Weta, another German shepherd has also completed a randomised controlled trial, held over 5 consecutive days testing 300 samples. Her results were 100% specificity success and 100% sensitivity success.
Ethics approval has been granted along with approval from Southern Cross Invercargill to collect patient urine samples for our stage two research. Once associated clinical requirements have been approved for other regions further samples will be collected. K9MD Levi and K9MD Weta have now commenced the "Diagnostic Accuracy" stage to estimate sensitivity and specificity with patient urine samples in real world conditions.
It is hoped that the findings from this research programme will assist in the development of a new early diagnostic alternative for bowel cancer in New Zealand.