Recruiting

Liquid Biopsy

Sponsor:

City of Hope Medical Center

Code:

NCT05384769

Conditions

Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Liquid Biopsy

Low Dose Computed Tomography of the Chest

Survey Administration

Study Details

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

Study ID

NCT05384769

Start date

Jul 29, 2022

Status verified date

Oct, 2025

Completion date

Jan 28, 2029

Anticipated

Primary completion date

Jan 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Cohort A (liquid biopsy, optional LDCT)

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

experimental: Cohort B (LDCT, optional liquid biopsy)

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

Interventions

Liquid Biopsy

Undergo liquid biopsy

Low Dose Computed Tomography of the Chest

Undergo low dose CT

Survey Administration

Ancillary studies

Primary outcome measure

  • Screening preference [ Time Frame: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks. ]

Central Contacts and Locations

Central contacts

Dan Raz, MD

626-359-8111draz@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Dan Raz

626-256-4673draz@coh.org

Principal Investigator:

Dan Raz

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-10-07.