Lung Cancer, Non-Small CellLumenDxNCT06963307
Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
An observational study of Lung Cancer, Non-Small Cell, run by JaxBio Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 100 patients with various types of lung cancer before starting their first systemic treatment (immunotherapy/chemo-immunotherapy). Samples will be taken before treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment. * 50 patients undergoing lung cancer surgery. Samples will be collected before surgery, 4-6 weeks after surgery, and 6-12 months post-surgery. * 50 patients with positive or inconclusive LDCT findings and negative biopsy results for lung cancer. * 50 patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis. * 50 healthy volunteers.
Who may be able to join
- 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 cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yael Michaeli, Ph.D. contact
About this study
Official title: LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
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.
Read the 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 methods. In addition, because the epigenetic pattern is dynamic and changes depending on the existing condition, epigenetic changes may allow the identification of the type of disease or serve as a marker for responsiveness to treatment.
The aim of the proposed study is to perform epigenetic mapping in cell-free DNA to identify genomic regions that differ in their epigenetic pattern between lung cancer patients of all histological types, patients with chronic lung diseases, patients with acute pneumonia, and healthy individuals. 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 examined 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. This method may allow early identification of MRD in lung cancer by cell-free DNA in the blood, thus influencing the method of treatment and significantly increasing the chances of survival for patients.
Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood sample will be obtained.
Lung cancer patients undergoing treatment will donate blood at the following time points: before starting their first systemic treatment (immunotherapy/chemo-immunotherapy) treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment.
Lung cancer patients undergoing surgery to remove lung cancer will donate blood at the following time points: before the surgery, 4-6 weeks after surgery, and 6-12 months post-surgery.
Patients with positive or inconclusive low-dose CT findings and negative biopsy results for lung cancer will be recruited to evaluate the ability of the test to assist in a more accurate diagnosis.
Patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis and 50 healthy volunteers will be recruited as control groups. These participate will donate blood once during the study.
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- lung cancer, liquid biopsy, cancer diagnostics, follow-up, minimal residual disease, cell-free DNA, epigenetics, DNA methylation, response to therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| Healthy controls | Healthy individuals will serve as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months from the first blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JaxBio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963307
- Sponsor's protocol ID
- 101188111
- Other IDs
- 101188111
- Acronym
- LumenDx
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMEN-Dx: Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT06963307
- Acronym / sponsor ID
- LumenDx / 101188111
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- lung cancer, liquid biopsy, cancer diagnostics, follow-up, minimal residual disease, cell-free DNA, epigenetics, DNA methylation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- JaxBio LtdIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 methods. In addition, because the epigenetic pattern is dynamic and changes depending on the existing condition, epigenetic changes may allow the identification of the type of disease or serve as a marker for responsiveness to treatment.
The aim of the proposed study is to perform epigenetic mapping in cell-free DNA to identify genomic regions that differ in their epigenetic pattern between lung cancer patients of all histological types, patients with chronic lung diseases, patients with acute pneumonia, and healthy individuals. 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 examined 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. This method may allow early identification of MRD in lung cancer by cell-free DNA in the blood, thus influencing the method of treatment and significantly increasing the chances of survival for patients.
Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood sample will be obtained.
Lung cancer patients undergoing treatment will donate blood at the following time points: before starting their first systemic treatment (immunotherapy/chemo-immunotherapy) treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment.
Lung cancer patients undergoing surgery to remove lung cancer will donate blood at the following time points: before the surgery, 4-6 weeks after surgery, and 6-12 months post-surgery.
Patients with positive or inconclusive low-dose CT findings and negative biopsy results for lung cancer will be recruited to evaluate the ability of the test to assist in a more accurate diagnosis.
Patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis and 50 healthy volunteers will be recruited as control groups. These participate will donate blood once during the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| Healthy controls | – | –Healthy individuals will serve as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 100 patients with various types of lung cancer before starting their first systemic treatment (immunotherapy/chemo-immunotherapy). Samples will be taken before treatment, 4-12 weeks after treatment initiation, and 6-12 months post-treatment. * 50 patients undergoing lung cancer surgery. Samples will be collected before surgery, 4-6 weeks after surgery, and 6-12 months post-surgery. * 50 patients with positive or inconclusive LDCT findings and negative biopsy results for lung cancer. * 50 patients with chronic lung disease or acute pneumonia, with no lung cancer diagnosis. * 50 healthy volunteers.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define a set of differential epigenetic biomarkers that uniquely identify lung cancer
Time frame: 12 months from the first blood draw
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yael Michaeli, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Non-Small Cell, run by JaxBio Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Michaeli, Ph.D. (yaelmi@jaxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define a set of differential epigenetic biomarkers that uniquely identify lung cancer (time frame: 12 months from the first blood draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.