Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
51 participants
OBSERVATIONAL
2020-01-13
2024-12-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood via HD-SCA fluid biopsy
Laboratory Biomarker Analysis
Correlative studies
Liquid Biopsy
Undergo collection of blood via HD-SCA fluid biopsy
Medical Chart Review
Review of medical chart
Interventions
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Biospecimen Collection
Undergo collection of blood via HD-SCA fluid biopsy
Laboratory Biomarker Analysis
Correlative studies
Liquid Biopsy
Undergo collection of blood via HD-SCA fluid biopsy
Medical Chart Review
Review of medical chart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Jorge J Nieva, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2019-05861
Identifier Type: REGISTRY
Identifier Source: secondary_id
2N-19-3
Identifier Type: OTHER
Identifier Source: secondary_id
2N-19-3
Identifier Type: -
Identifier Source: org_study_id
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