Early Diagnosis of Pulmonary Nodules

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Integrated Diagnostics

ClinicalTrials.gov Identifier:

NCT01752114

First received: November 30, 2012

Last updated: August 29, 2016

Last verified: August 2016

History of Changes

Purpose

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
Precancerous Conditions Carcinoma


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

Further study details as provided by Integrated Diagnostics:

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


Enrollment:	684
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752114

Show 33 Study Locations

Sponsors and Collaborators

Integrated Diagnostics

Investigators


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

More Information


Responsible Party:	Integrated Diagnostics
ClinicalTrials.gov Identifier:	NCT01752114 History of Changes
Other Study ID Numbers:	PANOPTIC (1001-12)
Study First Received:	November 30, 2012
Last Updated:	August 29, 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

ClinicalTrials.gov processed this record on August 16, 2017

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