- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162678
Fluid Biopsy for the Diagnosis of Lung Cancer
Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.
SECONDARY OBJECTIVES:
I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.
II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.
OUTLINE:
Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.
After completion of study, patients are followed for up to 1 year.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sandy Tran, RN
- Phone Number: 323-865-0451
- Email: sandy.tran@med.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Recruiting
- USC / Norris Comprehensive Cancer Center
-
Contact:
- Sandy Tran, RN
- Phone Number: 323-865-0451
- Email: sandy.tran@med.usc.edu
-
Principal Investigator:
- Jorge J. Nieva, MD
-
Los Angeles, California, United States, 90033
- Recruiting
- Los Angeles County-USC Medical Center
-
Contact:
- Sandy Tran, RN
- Phone Number: 323-865-0451
- Email: sandy.tran@med.usc.edu
-
Principal Investigator:
- Jorge J. Nieva, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Scheduled to undergo a diagnostic biopsy for possible lung cancer or
- Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
- Planning or completed in the last 2 weeks a CT lung cancer screen
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diagnostic (blood collection via fluid biopsy, lab analysis)
Patients undergo collection of blood samples on day 1 for analysis via HD-SCA fluid biopsy.
Medical charts of patients are reviewed at 3 months post-biopsy or CT screening.
|
Correlative studies
Review of medical chart
Other Names:
Undergo collection of blood via HD-SCA fluid biopsy
Undergo collection of blood via HD-SCA fluid biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical diagnosis of lung cancer
Time Frame: Within 90 days of tissue biopsy
|
Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.
|
Within 90 days of tissue biopsy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jorge J Nieva, MD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2N-19-3 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2019-05861 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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