Fluid Biopsy for the Diagnosis of Lung Cancer

Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Medical Chart Review; Procedure: Biospecimen Collection; Procedure: Liquid Biopsy

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: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Sandy Tran, RN; Phone Number: 323-865-0451; Email: sandy.tran@med.usc.edu

Study Locations

• United States
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a biopsy or CT screening for lung cancer

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?

Number of groups / cohorts

1

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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Medical Chart Review; Review of medical chart; Other Names: Chart Review; Procedure: Biospecimen Collection; Undergo collection of blood via HD-SCA fluid biopsy; Procedure: Liquid Biopsy; Undergo collection of blood via HD-SCA fluid biopsy; Other Names: Plasma Biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jorge J Nieva, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Estimated): January 13, 2025
• Study Completion (Estimated): January 13, 2026

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No