Early Diagnosis of Pulmonary Nodules

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ClinicalTrials.gov Identifier: NCT01752114

Recruitment Status : Completed

First Posted : December 19, 2012

Last Update Posted : March 1, 2018

Sponsor:

Information provided by (Responsible Party):

Integrated Diagnostics

Study Description

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.

Condition or disease
Precancerous Conditions Carcinoma

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 Design


Study Type :	Observational
Actual Enrollment :	684 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
Study Start Date :	October 2012
Actual Primary Completion Date :	December 31, 2016
Actual Study Completion Date :	December 31, 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer [ Time Frame: 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.

Biospecimen Retention: Samples With DNA

Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752114

Show 33 Study Locations

Sponsors and Collaborators

Integrated Diagnostics

Investigators


Study Director:	Russell F. Hudnall	Integrated Diagnostics, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Silvestri GA, Tanner NT, Kearney P, Vachani A, Massion PP, Porter A, Springmeyer SC, Fang KC, Midthun D, Mazzone PJ; PANOPTIC Trial Team. Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial. Chest. 2018 Mar 1. pii: S0012-3692(18)30307-6. doi: 10.1016/j.chest.2018.02.012. [Epub ahead of print]


Responsible Party:	Integrated Diagnostics
ClinicalTrials.gov Identifier:	NCT01752114 History of Changes
Other Study ID Numbers:	PANOPTIC (1001-12)
First Posted:	December 19, 2012 Key Record Dates
Last Update Posted:	March 1, 2018
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Integrated Diagnostics:


Precancerous conditions Carcinoma

Additional relevant MeSH terms:


Precancerous Conditions Multiple Pulmonary Nodules Neoplasms Lung Neoplasms Respiratory Tract Neoplasms	Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases

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