Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05384769
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Cell-Free DNA Liquid Biopsy in Screening High-Risk Patients for Lung Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-02513 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 21591 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |