Fluid Biopsy for the Diagnosis of Lung Cancer

Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04162678

Enrollment

Registered

2019-11-14

Start date

2020-01-13

Completion date

2024-12-09

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Carcinoma

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood via HD-SCA fluid biopsy

OTHERLaboratory Biomarker Analysis

Correlative studies

PROCEDURELiquid Biopsy

Undergo collection of blood via HD-SCA fluid biopsy

OTHERMedical Chart Review

Review of medical chart

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026