Clinical trial NCT05384769: Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
Official title: Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy At Home in High-Risk Current and Former Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-20
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Screening preference
timeFrame: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.
Secondary outcomes:
measure: Participants who follow-through on screening 1
timeFrame: 6 month follow-up timepoint.
measure: Participants who follow-through on screening 2
timeFrame: 6 month follow-up timepoint.
measure: Participants who follow-through on screening 3
timeFrame: 6 month follow-up timepoint.
measure: Participants who follow-through on screening 4
timeFrame: 6 month follow-up timepoint.
measure: Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results
timeFrame: Up to 6 months
measure: Sociodemographic factors (age, sex, race/ethnicity, educational background)
timeFrame: At baseline visit
measure: Survey scores across screening preference 1
timeFrame: At 6 month follow up
measure: Survey scores across screening preference 2
timeFrame: At 6 month follow up
measure: Survey scores across screening preference 3
timeFrame: At 6 month follow up
measure: Survey scores across screening preference 4
timeFrame: At 6 month follow up
measure: Survey scores across screening preference 5
timeFrame: At 6 month follow up
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Dan Raz, MD
role: PRINCIPAL_INVESTIGATOR
References: