Actively Recruiting
LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
Led by JaxBio Ltd · Updated on 2025-05-09
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new method to detect lung cancer using epigenetic patterns found in cell-free DNA from blood samples. This observational study seeks to identify unique epigenetic markers that can help distinguish lung cancer from other lung diseases and healthy states. The goal is to develop a simple blood test that could improve early diagnosis, monitor treatment response, and detect minimal residual disease after surgery or treatment. Participants include lung cancer patients before and after treatment or surgery, patients with chronic lung diseases or acute pneumonia, and healthy volunteers as control groups. Blood samples will be collected at specific time points depending on the participant group, such as before treatment, several weeks after treatment or surgery, and up to 12 months post-treatment or surgery. Control participants will provide a single blood sample during the study. During the study, participants will undergo blood draws and provide informed consent before enrollment. Researchers will analyze the blood samples to identify epigenetic biomarkers linked to lung cancer and assess their ability to assist in diagnosis and treatment monitoring. The primary outcome is to define a set of epigenetic markers that uniquely identify lung cancer within 12 months from the first blood draw. The study will enroll about 300 participants over roughly 18 months.
CONDITIONS
Brief Title
Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 18 years old
- Patients diagnosed with lung cancer before systemic therapy
- Patients with inconclusive low-dose CT findings
- Healthy volunteers
- Patients with chronic lung diseases such as COPD, pulmonary emphysema, or acute pneumonia
You will not qualify if you...
- Individuals who did not sign a consent form
- Patients diagnosed with cancers other than lung cancer
- Patients with HIV or hepatitis
- Patients with active autoimmune diseases except lung-localized diseases
- Pregnant women or those unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single time point during study
Participants with inconclusive low-dose CT findings and negative biopsy results undergo blood sampling to assist in more accurate diagnosis.
1 visit (in-person)
Duration - Up to 12 months
Lung cancer patients undergoing systemic treatment donate blood before treatment, 4 to 12 weeks after treatment initiation, and 6 to 12 months post-treatment to monitor epigenetic changes.
3 visits (in-person)
Duration - Up to 12 months
Lung cancer patients undergoing surgery donate blood before surgery, 4 to 6 weeks after surgery, and 6 to 12 months post-surgery to assess minimal residual disease and treatment success.
3 visits (in-person)
Duration - Single time point during study
Participants with chronic lung diseases or healthy volunteers donate blood once during the study to serve as control groups in identifying lung cancer epigenetic biomarkers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
Research Team
Y
Yael Michaeli, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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