Early Diagnosis of Pulmonary Nodules

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Integrated Diagnostics
Sponsor:
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752114
First received: November 30, 2012
Last updated: September 18, 2014
Last verified: September 2014

November 30, 2012
September 18, 2014
October 2012
December 2017   (final data collection date for primary outcome measure)
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer [ Time Frame: 2 years post enrollment ] [ Designated as safety issue: No ]
Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
Same as current
Complete list of historical versions of study NCT01752114 on ClinicalTrials.gov Archive Site
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Early Diagnosis of Pulmonary Nodules
Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples

Non-Probability Sample

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

  • Precancerous Conditions
  • Carcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
United States,   Canada
 
NCT01752114
1001-12
No
Integrated Diagnostics
Integrated Diagnostics
Not Provided
Study Director: Adam Callahan Integrated Diagnostics, Inc.
Integrated Diagnostics
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP