Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05384769

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Dan Raz

CONTACT

[email protected]

626-256-4673

Dan Raz

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liquid Biopsy

Procedure

Undergo liquid biopsy

Other names: Plasma Biopsy

Low Dose Computed Tomography of the Chest

Procedure

Undergo low dose CT

Other names: LDCT, Low Dose Chest Computed Tomography, Low-dose Chest Computed Tomography, Low-dose Chest CT

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Screening preference

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

    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.

Secondary outcomes

  1. Participants who follow-through on screening 1

    Time frame: 6 month follow-up timepoint.

    The proportion of participants who are screened with LDCT at 6 months in each screening group.

  2. Participants who follow-through on screening 2

    Time frame: 6 month follow-up timepoint.

    The proportion of participants who undergo LDCT at 6 months after receiving liquid biopsy results, stratified by test result (negative vs positive).

  3. Participants who follow-through on screening 3

    Time frame: 6 month follow-up timepoint.

    Differences in sociodemographic factors across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).

  4. Participants who follow-through on screening 4

    Time frame: 6 month follow-up timepoint.

    Differences in sociodemographic survey scores across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).

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

    Time frame: Up to 6 months

    For those who choose liquid biopsy only. Data will be summarized using counts and percentages and tested using Chi-square analysis.

  6. Sociodemographic factors (age, sex, race/ethnicity, educational background)

    Time frame: At baseline visit

    Data will be summarized using means and standard deviations or counts and percentages, depending on whether the data are continuous or categorical. Univariate tests across groups will be done using t-tests (continuous) and chi-square analysis (categorical). Non-parametric tests will be used for continuous data that are non-normally distributed data (Kruskal-Wallis) and for ordinal categorical data (Jonckheere-Terpstra). Multivariable logistic regression methods will be used to determine the primary factors predicting screening preference. Data included in the model will be determined based on clinical relevance and/or significance in univariate analysis.

  7. Survey scores across screening preference 1

    Time frame: At 6 month follow up

    Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.

    Survey tools utilized:Demographics tool: including sex, race/ethnicity, education level, income.

  8. Survey scores across screening preference 2

    Time frame: At 6 month follow up

    Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.

    Survey tools utilized: Tobacco smoking history

  9. Survey scores across screening preference 3

    Time frame: At 6 month follow up

    Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.

    Survey tools utilized: Prior use of colon, breast, and lung cancer screening.

  10. Survey scores across screening preference 4

    Time frame: At 6 month follow up

    Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.

    Survey tools utilized: Lung Cancer Screening Health Beliefs Survey (lung cancer risk perception and barriers to lung cancer screening).

  11. Survey scores across screening preference 5

    Time frame: At 6 month follow up

    Survey tools will be used to understand sociodemographics, prior cancer screening, cancer worry, lung cancer risk perception, and barriers to lung cancer screening.

    Survey tools utilized: Cancer Worry Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Raz, MD

CONTACT

[email protected]

626-359-8111

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
May 20, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.