Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Non-Small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Lung cancer patients
- description
- lung cancer patients will be recruited at diagnosis. Blood will be taken before surgery / treatment and after surgery / treatment at the indicated time points.
- label
- non-malignant lung disease
- description
- Non-malignant lung disease cohort includes patients with chronic lung disease such as COPD, or acute pneumonia, and will serve as a control group to identify lung cancer and distinguish it from other lung diseases.
- label
- Healthy controls
- description
- Healthy individuals will serve as a control group.
Primary outcomes (1)
- measure
- Define a set of differential epigenetic biomarkers that uniquely identify lung cancer
- timeFrame
- 12 months from the first blood draw
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available