Clinical Trials Logo

Clinical Trial Summary

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.

There are three Specific Aims of this study:

1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.

2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.

3. Assess the safety and tolerability of the ProLung Test procedures.

Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01566682
Study type Observational
Source Fresh Medical Laboratories
Contact
Status Completed
Phase
Start date October 2012
Completion date March 2019

See also
  Status Clinical Trial Phase
Terminated NCT05066776 - Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
Completed NCT01958931 - Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer N/A
Recruiting NCT03528733 - Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection N/A
Recruiting NCT02693496 - Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research
Terminated NCT02983903 - Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions N/A
Terminated NCT02050724 - ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT Phase 2
Not yet recruiting NCT04615156 - 18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography Phase 3
Recruiting NCT02726633 - Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer N/A
Active, not recruiting NCT02623712 - The Watch the Spot Trial N/A
Recruiting NCT03568799 - 4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules N/A
Not yet recruiting NCT02817048 - Tubeless VATS for Peripheral Lung Nodule N/A
Recruiting NCT01149187 - Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules N/A
Completed NCT00925210 - Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Phase 2
Completed NCT02448225 - 18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules Phase 2
Active, not recruiting NCT05171491 - LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Terminated NCT04140474 - Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules. N/A
Withdrawn NCT05804435 - iNod™ Ultrasound-Guided Needle Biopsy System Study N/A
Not yet recruiting NCT02653859 - Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules N/A
Completed NCT02832284 - iNod System Human Feasibility Assessment N/A
Recruiting NCT02773992 - Clinical Study of Three Plus Two Type Early Diagnosis of Pulmonary Nodules in Medical Internet of Things N/A