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RECRUITINGOBSERVATIONAL

Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer

LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - Subjects who did not sign a consent form. - Patients with cancer other than lung cancer. - Patients with HIV or hepatitis. - Patients with active autoimmune conditions (where your immune system attacks your own body)s (except lung-localized diseases). - Pregnant women or individuals unable to give willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (1)

Sheba Medical Center
Ramat Gan, Israel