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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Survey Administration; Procedure: Liquid Biopsy; Procedure: Low Dose Computed Tomography of the Chest

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Dan Raz; Phone Number: 626-256-4673; Email: draz@coh.org
      • Principal Investigator: Dan Raz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Procedure: Liquid Biopsy; Undergo liquid biopsy; Other Names: Plasma Biopsy; Procedure: Low Dose Computed Tomography of the Chest; Undergo low dose CT; Other Names: LDCT; Low Dose Chest Computed Tomography; Low-dose Chest Computed Tomography; Low-dose Chest CT
Experimental: Cohort B (LDCT, optional liquid biopsy); Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.	Other: Survey Administration; Ancillary studies; Procedure: Liquid Biopsy; Undergo liquid biopsy; Other Names: Plasma Biopsy; Procedure: Low Dose Computed Tomography of the Chest; Undergo low dose CT; Other Names: LDCT; Low Dose Chest Computed Tomography; Low-dose Chest Computed Tomography; Low-dose Chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants who follow-through on screening 1	The proportion of participants who are screened with LDCT at 6 months in each screening group.	6 month follow-up timepoint.
Participants who follow-through on screening 2	The proportion of participants who undergo LDCT at 6 months after receiving liquid biopsy results, stratified by test result (negative vs positive).	6 month follow-up timepoint.
Participants who follow-through on screening 3	Differences in sociodemographic factors across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).	6 month follow-up timepoint.
Participants who follow-through on screening 4	Differences in sociodemographic survey scores across screening preference (liquid biopsy vs. LDCT) in those who undergo screening (Exploratory).	6 month follow-up timepoint.
Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results	For those who choose liquid biopsy only. Data will be summarized using counts and percentages and tested using Chi-square analysis.	Up to 6 months
Sociodemographic factors (age, sex, race/ethnicity, educational background)	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.	At baseline visit
Survey scores across screening preference 1	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.	At 6 month follow up
Survey scores across screening preference 2	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	At 6 month follow up
Survey scores across screening preference 3	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.	At 6 month follow up
Survey scores across screening preference 4	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).	At 6 month follow up
Survey scores across screening preference 5	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	At 6 month follow up

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dan Raz, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): January 28, 2026
• Study Completion (Estimated): January 28, 2026

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21591 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-02513 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No