Fluid Biopsy for the Diagnosis of Lung Cancer

Recruiting

• Conditions: Lung Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Procedure: Liquid Biopsy; Other: Medical Chart Review

• Registration Number: NCT04162678
• Lead Sponsor: University of Southern California

Brief 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.

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 Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2020-01-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-29
• Last Update Posted: 2024-08-30
• Primary Completion: 2026-01-13
• Study Completion: 2027-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (blood collection via fluid biopsy, lab analysis)	Biospecimen Collection	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.
Diagnostic (blood collection via fluid biopsy, lab analysis)	Laboratory Biomarker 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.
Diagnostic (blood collection via fluid biopsy, lab analysis)	Liquid Biopsy	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.
Diagnostic (blood collection via fluid biopsy, lab analysis)	Medical Chart Review	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.

Primary Outcome Measures

Name	Time	Method
Clinical diagnosis of lung cancer	Within 90 days of tissue biopsy	Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.

Trial Locations

Locations (2)

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States