Lung EpiCheck Biomarkers Development Study

Nucleix

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Blood collection

Study type: Observational

Funder types: Industry

Identifiers

NCT06245876

Evergreen-LNG-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

6,000 participants in 3 patient groups

Cases Cohort

Description:

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.

Treatment:

Other: Blood collection

USPSTF At Risk - Control Cohort

Description:

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

Treatment:

Other: Blood collection

Healthy Control Cohort

Description:

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

Treatment:

Other: Blood collection