Early Diagnosis of Pulmonary Nodules

Completed

• Conditions: Carcinoma; Precancerous Conditions

• Registration Number: NCT01752114
• Lead Sponsor: Integrated Diagnostics

Brief 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.

Detailed Description

Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-19
• Status Verified: 2016-08
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 684

Inclusion 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

Exclusion 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer	2 years post enrollment	Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.

Trial Locations

Locations (33)

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

Pulmonary Associates of Southern Arizona; 🇺🇸 Tucson, Arizona, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Georgia Lung Associates; 🇺🇸 Austell, Georgia, United States

Suburban Lung Associates; 🇺🇸 Elk Grove Village, Illinois, United States

Kentuckiana Pulmonary Associates; 🇺🇸 Louisville, Kentucky, United States

Pulmonary & Crit Care Associates of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

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