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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05384769
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Liquid Biopsy — PROCEDURE
    Undergo liquid biopsy
  • Low Dose Computed Tomography of the Chest — PROCEDURE
    Undergo low dose CT
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 29, 2022
Status verified
Oct 2025
Primary completion
Jan 28, 2029
Completion
Jan 28, 2029

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Dan Raz
626-256-4673
Dan Raz (PRINCIPAL_INVESTIGATOR)

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