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

NCT05384769 | Recruiting DMC

• 3 other identifiers: 21591NCI-2022-02513P30CA033572
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Screening preference

  The proportion of participants who agree to undergo lung cancer screening using liquid biopsy versus LDCT, with a feasibility threshold of at least 30% preferring liquid biopsy.

  Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.

Secondary Outcomes (11)

• Participants who follow-through on screening 1

  6 month follow-up timepoint.

• Participants who follow-through on screening 2

  6 month follow-up timepoint.

• Participants who follow-through on screening 3

  6 month follow-up timepoint.

• Participants who follow-through on screening 4

  6 month follow-up timepoint.

• Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results

  Up to 6 months

Study Arms (2)

Cohort A (liquid biopsy, optional LDCT)

EXPERIMENTAL

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

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

Cohort B (LDCT, optional liquid biopsy)

EXPERIMENTAL

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

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

Interventions

Liquid Biopsy PROCEDURE

Undergo liquid biopsy

Also known as: Plasma Biopsy

Cohort A (liquid biopsy, optional LDCT); Cohort B (LDCT, optional liquid biopsy)

Low Dose Computed Tomography of the Chest PROCEDURE

Undergo low dose CT

Also known as: LDCT, Low Dose Chest Computed Tomography, Low-dose Chest Computed Tomography, Low-dose Chest CT

Cohort A (liquid biopsy, optional LDCT); Cohort B (LDCT, optional liquid biopsy)

Survey Administration OTHER

Ancillary studies

Cohort A (liquid biopsy, optional LDCT); Cohort B (LDCT, optional liquid biopsy)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Dan Raz, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Raz, MD

CONTACT

626-359-8111; draz@coh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 20, 2022
• Study Start: July 29, 2022
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): January 28, 2029
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (1)