Fluid Biopsy for the Diagnosis of Lung Cancer

NCT04162678 | Terminated DMC

• 3 other identifiers: 2N-19-3NCI-2019-05861P30CA014089
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Clinical diagnosis of lung cancer

  Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.

  Within 90 days of tissue biopsy

Study Arms (1)

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood via HD-SCA fluid biopsy

Diagnostic (blood collection via fluid biopsy, lab analysis)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (blood collection via fluid biopsy, lab analysis)

Liquid Biopsy PROCEDURE

Undergo collection of blood via HD-SCA fluid biopsy

Also known as: Plasma Biopsy

Diagnostic (blood collection via fluid biopsy, lab analysis)

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Diagnostic (blood collection via fluid biopsy, lab analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a biopsy or CT screening for lung cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Jorge J Nieva, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: January 13, 2020
• Primary Completion: December 5, 2024
• Study Completion: December 9, 2024
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (2)