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

NCT06963307 | Recruiting

• 1 other identifier: 101188111
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• JaxBio Ltd: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and separated to plasma and buffy coat. Cell-free DNA will be extracted from the plasma.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yael Michaeli, Ph.D.

CONTACT

yaelmi@jaxbio.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)