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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
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• 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.

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Dan Raz, MD
draz@coh.org
626-359-8111
Time Frame
Start Date: 2022-07-29
Estimated Completion Date: 2029-01-28
Participants
Target number of participants: 108
Treatments
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.
Experimental: Cohort B (LDCT, optional liquid biopsy)
Participants undergo low dose CT with optional liquid biopsy on the same day as LDCT.
Authors
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov