Clinical trial NCT06963307: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
Official title: LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer, Non-Small Cell
Keywords: lung cancer
liquid biopsy
cancer diagnostics
follow-up
minimal residual disease
cell-free DNA
epigenetics
DNA methylation
response to therapy
Lead sponsor: JaxBio Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 100 patients with various types of lung cancer before starting their first systemic treatment (immunotherapy/chemo-immunotherapy). Samples will be taken before treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment.
* 50 patients undergoing lung cancer surgery. Samples will be collected before surgery, 4-6 weeks after surgery, and 6-12 months post-surgery.
* 50 patients with positive or inconclusive LDCT findings and negative biopsy results for lung cancer.
* 50 patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis.
* 50 healthy volunteers.

Brief summary: This trial is a multicenter, open-label, non-interventional controlled study to identify and characterize epigenetic signatures of lung cancer. The goal of this study is to develop a simple blood test that can detect lung cancer with high sensitivity, and assist in the early diagnosis and management of lung cancer.

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 evaluated, 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.

The collection of patients and data will be conducted over a period of about a year and a half, with the aim of reaching approximately 300 participants, including patients with lung cancer before and after treatment/surgery and control groups.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years old.
* Patients diagnosed with lung cancer before systemic therapy.
* Patients with inconclusive LDCT findings.
* Healthy volunteers.
* Patients with chronic lung diseases (COPD, pulmonary emphysema, acute pneumonia).

Exclusion Criteria:

* Subjects who did not sign a consent form.
* Patients with cancer other than lung cancer.
* Patients with HIV or hepatitis.
* Patients with active autoimmune diseases (except lung-localized diseases).
* Pregnant women or individuals unable to give informed consent.

Primary outcomes:
measure: Define a set of differential epigenetic biomarkers that uniquely identify lung cancer
timeFrame: 12 months from the first blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: