Fluid Biopsy for the Diagnosis of Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Laboratory Biomarker Analysis
* Procedure: Liquid Biopsy
* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (blood collection via fluid biopsy, lab analysis)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of blood via HD-SCA fluid biopsy<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Liquid Biopsy<br>* Undergo collection of blood via HD-SCA fluid biopsy<br>* Other names: Plasma Biopsy;Other: Medical Chart Review<br>* Review of medical chart<br>* Other names: Chart Review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical diagnosis of lung cancer | Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated. | Within 90 days of tissue biopsy |