Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer

Recruiting · NCT05384769 · Interventional (participants receive a specific treatment) · Lead sponsor: City of Hope Medical Center

View the official record on ClinicalTrials.gov →

Lung cancer

Interventions studied

Liquid BiopsyLow Dose Computed Tomography of the ChestSurvey Administration

What this trial is about

This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.

Who can take part

Age range

50 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Documented written informed consent of the participant.
Age 50-80 years.
Smoking history of \>= 20 pack-years and if quit, quit within 15 years.
Received referral for counseling for lung cancer screening and would qualify for LDCT.
Health Insurance that will pay for a LDCT for lung cancer screening at either City of Hope Duarte, Newport Beach (Newport Diagnostic Imaging), or Lancaster (Renaissance Imaging/Antelope Valley Outpatient Imaging Center).
Willingness to provide blood sample.
English speaking.
Consent to undergo lung cancer screening with either liquid biopsy (LB) or LDCT.

Exclusion criteria

Symptoms of lung cancer.
Chest CT scan or chest positron emission tomography (PET)/CT within 12 months.
Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer.
Unable to undergo LDCT at either City of Hope Duarte, Newport Beach, or Lancaster.

Where it is running

1 location listed across 1 US state.

City of Hope Medical Center - Duarte, California, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →