beta
Trial Radar AI
Clinical Trial NCT06963307 (LumenDx) for Lung Cancer, Non-Small Cell is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer (LumenDx) 300 Open-Label Novel Treatment

Recruiting
Clinical Trial NCT06963307 (LumenDx) is an observational study for Lung Cancer, Non-Small Cell that is recruiting. It started on 1 May 2025 with plans to enroll 300 participants. Led by JaxBio Ltd, it is expected to complete by 1 November 2026. The latest data from ClinicalTrials.gov was last updated on 9 May 2025.
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 treat...

Show More
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...Show More
Official Title

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

Conditions
Lung Cancer, Non-Small Cell
Other Study IDs
  • LumenDx
  • 101188111
  • 101188111 (Other Grant/Funding Number) (EU)
NCT ID Number
NCT06963307
Start Date (Actual)
2025-05
Last Update Posted
2025-05-09
Completion Date (Estimated)
2026-11
Enrollment (Estimated)
300
Study Type
Observational
Status
Recruiting
Keywords
lung cancer
liquid biopsy
cancer diagnostics
follow-up
minimal residual disease
cell-free DNA
epigenetics
DNA methylation
response to therapy
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Lung cancer patients
lung cancer patients will be recruited at diagnosis. Blood will be taken before surgery / treatment and after surgery / treatment at the indicated time points.
N/A
non-malignant lung disease
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.
N/A
Healthy controls
Healthy individuals will serve as a control group.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Define a set of differential epigenetic biomarkers that uniquely identify lung cancer
Define a set of differential epigenetic biomarkers that uniquely identify lung cancer and can assist in companion diagnostics, evaluate treatment response, predict response to therapy, and detect minimal residual disease following surgery or treatment
12 months from the first blood draw
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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).

  • 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.
JaxBio Ltd logoJaxBio Ltd
Study Central Contact
Contact: Yael Michaeli, Ph.D., [email protected]
1 Study Locations in 1 Countries
Sheba Medical Center, Ramat Gan, Israel
Recruiting