Detecting lung cancer through blood tests using DNA analysis
LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
This study is testing a new blood test that looks for signs of lung cancer by analyzing DNA from dying cancer cells to see if it can help with early detection and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | JaxBio Ltd Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT06963307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify and characterize epigenetic signatures in cell-free DNA to develop a blood test for lung cancer detection. By analyzing DNA released from dying cancer cells, the study seeks to enhance existing diagnostic methods, predict treatment responses, and monitor minimal residual disease (MRD) in patients. Approximately 300 participants, including lung cancer patients and healthy controls, will be enrolled over a year and a half to evaluate the effectiveness of this approach in early diagnosis and treatment management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with lung cancer, those with inconclusive lung imaging results, and healthy volunteers.
Not a fit: Patients with cancers other than lung cancer or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive blood test that allows for early detection and better management of lung cancer.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ramat Gan
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
Study contacts
- Study coordinator: Yael Michaeli, Ph.D.
- Email: yaelmi@jaxbio.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.