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

City of Hope

Status: Enrolling

Conditions: Lung Carcinoma

Treatments: Procedure: Liquid Biopsy; Procedure: Low Dose Computed Tomography of the Chest; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05384769

NCI-2022-02513 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

21591

Details and patient eligibility

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.

Full description

PRIMARY OBJECTIVE:

I. To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.

SECONDARY OBJECTIVES:

I. To determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus [vs] LDCT).

II. To determine the rate of LDCT following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive).

III. To compare participant sociodemographic factors (age, sex, race/ethnicity, educational background) and survey scores across screening preference (liquid biopsy vs. LDCT).

OUTLINE: Participants choose 1 of 2 cohorts.

COHORT A: Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.

COHORT B: Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.

After completion of study, patients are followed up at 6 months.

Enrollment: 108 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Cohort A (liquid biopsy, optional LDCT)

Experimental group

Description:

Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive.

Treatment:

Other: Survey Administration

Procedure: Low Dose Computed Tomography of the Chest

Procedure: Liquid Biopsy

Cohort B (LDCT, optional liquid biopsy)

Experimental group

Description:

Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.

Treatment:

Other: Survey Administration

Procedure: Low Dose Computed Tomography of the Chest

Procedure: Liquid Biopsy