Lung EpiCheck Biomarkers Development Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases Cohort

Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects.

Blood collection

Intervention Type OTHER

Blood collection

USPSTF At Risk - Control Cohort

Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years.

Blood collection

Intervention Type OTHER

Blood collection

Healthy Control Cohort

Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years.

Blood collection

Intervention Type OTHER

Blood collection

Interventions

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Blood collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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

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

Exclusion Criteria

* 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

\- 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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes