Lung CarcinomaNCT05384769
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
A study testing Liquid Biopsy, Low Dose Computed Tomography of the Chest and Survey Administration in people with Lung Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Liquid Biopsy, Low Dose Computed Tomography of the Chest and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 28 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.
SECONDARY OBJECTIVES:
- 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
- Lung Carcinoma
- Being tested
- Liquid Biopsy, Low Dose Computed Tomography of the Chest, Survey Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid BiopsyProcedure or surgery
Also called Plasma Biopsy
Undergo liquid biopsy
Low Dose Computed Tomography of the ChestProcedure or surgery
Also called LDCT, Low Dose Chest Computed Tomography, Low-dose Chest Computed Tomography, Low-dose Chest CT
Undergo low dose CT
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (liquid biopsy, optional LDCT) | Experimental | Participants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive. Receives: Procedure: Liquid Biopsy; Procedure: Low Dose Computed Tomography of the Chest; Other: Survey Administration |
| Cohort B (LDCT, optional liquid biopsy) | Experimental | Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT. Receives: Procedure: Liquid Biopsy; Procedure: Low Dose Computed Tomography of the Chest; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.
Secondary outcomes (11)
Participants who follow-through on screening 1
The proportion of participants who are screened with LDCT at 6 months in each screening group.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: At 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start29 Jul 2022
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dan Raz, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384769
- Sponsor's protocol ID
- 21591
- Other IDs
- NCI-2022-02513, 21591, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers
- ClinicalTrials.gov ID
- NCT05384769
- Acronym / sponsor ID
- 21591
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (liquid biopsy, optional LDCT) | Experimental | Procedure: Liquid Biopsy, Procedure: Low Dose Computed Tomography of the Chest, Other: Survey AdministrationParticipants undergo collection of blood sample (liquid biopsy), with option to undergo LDCT if liquid biopsy results are positive. |
| Cohort B (LDCT, optional liquid biopsy) | Experimental | Procedure: Liquid Biopsy, Procedure: Low Dose Computed Tomography of the Chest, Other: Survey AdministrationParticipants undergo low dose CT with optional liquid biopsy on the same day as LDCT. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid BiopsyAlso: Plasma BiopsyUndergo liquid biopsy | Procedure or surgery | Cohort A (liquid biopsy, optional LDCT), Cohort B (LDCT, optional liquid biopsy) |
| Low Dose Computed Tomography of the ChestAlso: LDCT, Low Dose Chest Computed Tomography, Low-dose Chest Computed Tomography, Low-dose Chest CTUndergo low dose CT | Procedure or surgery | Cohort A (liquid biopsy, optional LDCT), Cohort B (LDCT, optional liquid biopsy) |
| Survey AdministrationAncillary studies | Other | Cohort A (liquid biopsy, optional LDCT), Cohort B (LDCT, optional liquid biopsy) |
Primary outcome
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.
11 secondary outcomes
Participants who follow-through on screening 1
Time frame: 6 month follow-up timepoint.
Participants who follow-through on screening 2
Time frame: 6 month follow-up timepoint.
Participants who follow-through on screening 3
Time frame: 6 month follow-up timepoint.
Participants who follow-through on screening 4
Time frame: 6 month follow-up timepoint.
Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results
Time frame: Up to 6 months
Sociodemographic factors (age, sex, race/ethnicity, educational background)
Time frame: At baseline visit
Survey scores across screening preference 1
Time frame: At 6 month follow up
Survey scores across screening preference 2
Time frame: At 6 month follow up
Survey scores across screening preference 3
Time frame: At 6 month follow up
Survey scores across screening preference 4
Time frame: At 6 month follow up
Survey scores across screening preference 5
Time frame: At 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Raz, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Biopsy, Low Dose Computed Tomography of the Chest and Survey Administration in people with Lung Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening preference (time frame: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.