Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Diagnosis of Pulmonary Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 30, 2012
First Posted Date December 19, 2012
Last Update Posted Date March 1, 2018
Study Start Date October 2012
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Diagnosis of Pulmonary Nodules
Official Title Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
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
Condition
  • Precancerous Conditions
  • Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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 Sep;154(3):491-500. doi: 10.1016/j.chest.2018.02.012. Epub 2018 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2016)
684
Original Estimated Enrollment
 (submitted: December 17, 2012)
1600
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01752114
Other Study ID Numbers PANOPTIC (1001-12)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Integrated Diagnostics
Study Sponsor Integrated Diagnostics
Collaborators Not Provided
Investigators
Study Director: Russell F. Hudnall Integrated Diagnostics, Inc.
PRS Account Integrated Diagnostics
Verification Date August 2016