Lung EpiCheck Biomarkers Development Study

Summary

This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.

Eligibility

Inclusion Criteria - Cases:

* Age 50-80 years
* Subjects who are currently smoking or former smokers, with at least 20 pack-years
* Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.

Exclusion Criteria - Cases

* Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer

Inclusion Criteria - USPSTF risk

* Age 50-80 years
* Subjects who are currently smoking or former smokers, with at least 20 pack-years

Exclusion Criteria - USPSTF risk

\- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix

Inclusion Criteria - Healthy controls

* Age 20-80 years
* Never smoker or current / previous smoker \< 20 pack year history

Exclusion Criteria - Healthy Controls

* Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
* Not previously diagnosed with a lung lesion highly suspicious for cancer
* Under follow up or work up for any lesion suspicious for any type of cancer
* Presenting with fever with body temperature 100.4°F (38°C) or higher
* Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
* Pregnancy
* Any history of blood product transfusion within 30 days prior to blood draw

Conditions2

Locations6 sites

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