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Determination and Validation of Lung EpiCheck; a Multianalyte Assay for Lung Cancer Prediction

Lung-RND-003: Determination and Validation of Lung EpiCheck; a Multianalyte Assay for Lung Cancer Prediction A Case-Control Study

  • Clinical Trial Information

    Trial Contact: Deronvil, France

    Trial Phone: 321.841.3498

  • IRB No: 21.061.04

    Protocol Abbrev: Lung EpiCheck

    Principal Investigator: Luis J. Herrera, MD

    Age Group: Adult

    Secondary Protocol No: Lung-RND-003, Lung EpiCheck

    ClinicalTrials.gov ID: NCT04968548

  • Objective

    The main purpose of the study is to collect blood samples and medical data from you to help Nucleix in the development of a test that aims to differentiate between individuals at high risk with and without lung cancer. The test may allow for the early detection of stage I and II lung cancer tumors in patients at high-risk from a simple blood sample.

  • Key Eligibility

    Screening Series:
    1. Age 50-80 years
    2. Subjects who are willing and able to provide written informed consent
    3. Subjects who are currently smoking or former smokers, with at least 20 pack-years
    4. Individuals planned to undergo or have undergone LDCT for lung cancer screening within 60 days of date of blood collection

    Case Series:
    1. Age 50-80 years
    2. Subjects who are willing and able to provide written informed
    consent.
    3. Subjects who are currently smoking or former smokers, with
    at least 20 pack-years
    4. Subjects with either:
    A high suspicion for lung cancer, with planned biopsy or
    surgery to establish a definitive diagnosis within 60 days after
    date of blood collection
    OR
    Confirmed lung cancer diagnosis, however did not yet
    undergo any surgery, chemotherapy, radiation or any other
    treatment for this cancerous lesion (including, but not limited
    to systemic therapies)