Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
NCT ID: NCT05384769
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2022-07-29
2029-01-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Liquid Biopsy
Undergo liquid biopsy
Low Dose Computed Tomography of the Chest
Undergo low dose CT
Survey Administration
Ancillary studies
Cohort B (LDCT, optional liquid biopsy)
Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.
Liquid Biopsy
Undergo liquid biopsy
Low Dose Computed Tomography of the Chest
Undergo low dose CT
Survey Administration
Ancillary studies
Interventions
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Liquid Biopsy
Undergo liquid biopsy
Low Dose Computed Tomography of the Chest
Undergo low dose CT
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Dan Raz, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2022-02513
Identifier Type: REGISTRY
Identifier Source: secondary_id
21591
Identifier Type: OTHER
Identifier Source: secondary_id
21591
Identifier Type: -
Identifier Source: org_study_id
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