Early Diagnosis of Pulmonary Nodules

Study summary

This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 1, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?33 U.S. locations

Locations may change over time.

Who runs it?Integrated Diagnostics

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Integrated Diagnostics
Interventions being studied: Not specified

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Age ≥ 40 years
Smoking history: Never, Former, Current
Subject undergoing diagnostic evaluation for a lung nodule
Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
Nodule(s) identified by CT scan previously not followed
Subject willing to provide informed consent for the collection of blood specimens

Reasons someone may not be able to joinExclusion criteria

Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
Current diagnosis of any cancer
Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
History of human immunodeficiency virus (HIV) or Hepatitis C

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

St. Joseph's Hospital & Medical CenterPhoenix, Arizona
Pulmonary Associates of Southern ArizonaTucson, Arizona
University of Southern CaliforniaLos Angeles, California
California Pacific Medical CenterSan Francisco, California
Sarasota Memorial HospitalSarasota, Florida
Georgia Lung AssociatesAustell, Georgia
Suburban Lung AssociatesElk Grove Village, Illinois
Kentuckiana Pulmonary AssociatesLouisville, Kentucky
Pulmonary & Crit Care Associates of BaltimoreBaltimore, Maryland
Johns Hopkins Medical CenterBaltimore, Maryland
Baystate HealthSpringfield, Massachusetts
Henry Ford HospitalDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 1, 2018. Always confirm current availability with the study team.

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