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
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Clinical Trial Information
Trial Contact: Frankos, Marie; Rodriguez Saavedra, Carlis M; Simoni, Christine; Caldwell, Chloe M
Trial Phone: 321.841.7303 ; 321.841.6764 ; 321.841.7293 ; (321)841.1107
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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
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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.
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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)
