Fluid Biopsy for the Diagnosis of Lung Cancer

University of Southern California

Status: Terminated

Conditions: Lung Carcinoma

Treatments: Other: Medical Chart Review; Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Procedure: Liquid Biopsy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04162678

NCI-2019-05861 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

2N-19-3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 1 patient group

Diagnostic (blood collection via fluid biopsy, lab analysis)

Description:

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.

Treatment:

Procedure: Liquid Biopsy

Procedure: Biospecimen Collection

Other: Laboratory Biomarker Analysis

Other: Medical Chart Review