Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer (NCT05384769) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
United States108 participantsStarted 2022-07-29
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Screening preference
Timeframe: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.