During cell death, which occurs frequently in cancerous tissue, DNA from the dead cells
is released into the blood. This DNA has a unique epigenetic pattern that can indicate
the tissue of origin from which it was released. Therefore, cell-free DNA may serve as a
biomarker for monitoring tissues in which there is increased cell death and allow for
early detection of disease before it is even visible by other existing methods. In
addition, because the epigenetic pattern is dynamic and changes depending on the existing
condition, epigenetic changes may allow the identification of the type of disease or
serve as a marker for responsiveness to treatment.
The aim of the proposed study is to perform epigenetic mapping in cell-free DNA to
identify genomic regions that differ in their epigenetic pattern between lung cancer
patients of all histological types, patients with chronic lung diseases, patients with
acute pneumonia, and healthy individuals. In particular, the ability to assist existing
methods in cancer diagnostics, predict response to treatment, and assess the success of
treatment during and after treatment will be examined. In addition, the ability to assess
minimal residual disease (MRD) will be examined by taking blood after surgery to remove a
tumor or after treatment and testing whether there is any residual DNA from the tumor
using the markers that are found. This method may allow early identification of MRD in
lung cancer by cell-free DNA in the blood, thus influencing the method of treatment and
significantly increasing the chances of survival for patients.
Subjects will be screened for eligibility and then, after signing an Informed Consent
Form, the first peripheral blood sample will be obtained.
Lung cancer patients undergoing treatment will donate blood at the following time points:
before starting their first systemic treatment (immunotherapy/chemo-immunotherapy)
treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment.
Lung cancer patients undergoing surgery to remove lung cancer will donate blood at the
following time points: before the surgery, 4-6 weeks after surgery, and 6-12 months
post-surgery.
Patients with positive or inconclusive low-dose CT findings and negative biopsy results
for lung cancer will be recruited to evaluate the ability of the test to assist in a more
accurate diagnosis.
Patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis and
50 healthy volunteers will be recruited as control groups. These participate will donate
blood once during the study.