Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
ConditionLung Cancer, Non-Small Cell
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJaxBio Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women over 18 years old.
Patients diagnosed with lung cancer before systemic therapy.
Patients with inconclusive LDCT findings.
Healthy volunteers.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Lung cancer patients
Group B: non-malignant lung disease
Group C: Healthy controls
Trial outcomes
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
Time frame
12 months from the first blood draw Source ClinicalTrials.gov