Fluid Biopsy for the Diagnosis of Lung Cancer

Phase

N/A

Condition

Carcinoma

Treatment

Laboratory Biomarker Analysis

Biospecimen Collection

Liquid Biopsy

Clinical Study ID

NCT04162678

2N-19-3

NCI-2019-05861

2N-19-3

P30CA014089

Ages > 18
All Genders

Study Summary

This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.

Eligibility Criteria

Inclusion

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 yetundergone 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

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to enteringthe study
Known other solid tumor malignancy other than lung cancer requiring ongoing activetreatment

Study Design

Laboratory Biomarker Analysis

January 13, 2020

December 09, 2024

Study 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.

Connect with a study center

Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Site Not Available
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Active - Recruiting
Los Angeles County-USC Medical Center
Los Angeles 5368361, California 5332921 90033
United States
Site Not Available
USC / Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United States
Site Not Available

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