Fluid Biopsy for the Diagnosis of Lung Cancer

Last updated: August 29, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Laboratory Biomarker Analysis

Biospecimen Collection

Liquid Biopsy

Clinical Study ID

NCT04162678
2N-19-3
NCI-2019-05861
2N-19-3
P30CA014089
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 yetundergone 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

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to enteringthe study

  • Known other solid tumor malignancy other than lung cancer requiring ongoing activetreatment

Study Design

Total Participants: 75
Treatment Group(s): 4
Primary Treatment: Laboratory Biomarker Analysis
Phase:
Study Start date:
January 13, 2020
Estimated Completion Date:
January 13, 2027

Study 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.

Connect with a study center

  • Los Angeles County-USC Medical Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

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