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Therapy Monitoring Test for Cell-Free Tumour DNA
Patient information
Dear patient,
You are interested in a blood sample analysis test, which can provide an early
indication whether a chemotherapy or immunotherapy is effective. Below, we
explain what such a test can deliver, so that you may make an informed decision
whether to proceed with having such a test performed.
How does the test work?
In recent years many new scientific findings concerning cancer research have
been reported, which have led not only to new therapies but also to new
diagnostic methods. Today we know that in a very large number of cases a
tumour is indicated by substantial changes in the genetic material of the
degenerated cells. If a patient has such a tumour, then the genetic material is
different than that from all other normal cells of the body, and today we can
detect this difference with modern procedures.
Many tumors release their cellular content such as DNA into the bloodstream e.g.
due to cell death. These tumour-specific changes, at sufficiently high
concentration, can be detected and quantified as cell-free tumour DNA in the
blood.
This blood analysis to determine cell-free tumour DNA is a new tool, which can
help in the assessment of the efficacy of drug therapies in tumour diseases. The
CNI-Score we provide is reflecting the amount of circulating tumour DNA.
What can the test do for me?
There are several reasons to initiate a drug therapy, e.g. to reduce a diagnosed
malignant tumour prior to surgery. In such cases, combinations of drugs which
usually show the best anti-tumour efficacy are used.
However, the response of tumours to these drugs varies greatly from patient to
patient and ranges from complete regression of the tumour to complete
insensitivity of the tumour to the active substance. In some cases in special
therapy (immunotherapy), an even faster tumour growth can occur. Early
detection of either such an adverse event or insensitivity to drugs is important,
in order to switch therapy to another active substance. When undergoing a
therapy, the analysis of dynamic in the CNI-score levels can help your treating
physician to recognise e.g. the tumour’s insensitivity to current treatment earlier
and thus react faster, when other therapy options exist.
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How Is the Test Carried Out?
Before the start of the planned therapy, the initial value of the Test is
determined; this value will be the basis for controlling the course of treatment.
When this value – as compared to healthy people – is comparatively elevated,
then the tumour is eligible for the follow-up during the course of treatment,
using our test. Before the start of the second cycle of your therapy and, if
necessary, before the third cycle, another blood sampling is carried out and the
measured value is compared with the initial value.
What is the significance of this test?
We applied this method to study a large group of patients undergoing cancer
treatments. During the research study, traditional radiological observations of
the course of treatment were the benchmark for the assessment of tumours.
These observations distinguish progressive, stable and responsive tumours
depending on their size change detected with radiological methods. Often the
results of our test prior to the second therapy cycle show a sharp drop of
measured value, as compared to the initial value, which strongly indicates a
tumour’s response to treatment. If, on the other hand, the value significantly
increases, then despite therapy the disease most likely progresses. When the
change of value after the first therapy cycle is not particularly visible, in order to
assess the course of therapy another test before the start of the third cycle may
be recommended. During the research study of patients undergoing
immunotherapy, we were able to show that the reliability of our test was
significantly higher to those of conventional cancer markers whilst the results
obtained were on 6-9 weeks earlier than results from radiography.
This test is an addition to the various diagnostic measures available to you and
not a substitute. All other diagnostic measures performed in the course of your
cancer treatment shall remain unchanged and should be continued. Your doctor
will evaluate the results and take any treatment decisions, taking in addition to
this test also all other medical findings into account.
In conclusion, it can be said that the test is in particular useful in to detecting
situations where tumours are not responding well to the chosen therapy.
This test provides the possibility to relatively early detect such
situations, as described above.
After performing the test, it might be possible to introduce another,
modified form of therapy at an earlier stage.
What else must I know?
It is possible that in performing your test we discover inherited changes. You
have the right to know and the right not to know. You can decide whether we
should inform you of such incidental findings. If we determine that it is a change
indicative of a disease, then we will recommend a consultation with a geneticist
who can in depth explain such findings to you.
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I want to be informed of a finding of an inherited change in DNA:
yes / no (cross out whichever does not apply)
How shall the test be performed?
A sample of your blood will be drawn for the test before each therapy cycle. The
analysis report will be available approximately within 2 weeks.
Our laboratory has specialised expertise in performing the test described above.
The state-of-the-art procedures we employ are subject to continuous quality
control so that we can guarantee delivering to you the best possible test quality.
I have read and understood the above information. All questions I had have been
sufficiently answered. I agree to have the test performed and have been
informed that this innovative test, like any other test, does not provide complete
certainty.
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