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 16, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


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 ] [ 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.


Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 1600
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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
Genders Eligible for Study:   Both
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: Kenneth Fang, MD Integrated Diagnostics, Inc.
  More Information

No publications provided

Responsible Party: Integrated Diagnostics
ClinicalTrials.gov Identifier: NCT01752114     History of Changes
Other Study ID Numbers: 1001-12
Study First Received: November 30, 2012
Last Updated: September 16, 2014
Health Authority: United States: Quorum Review IRB

Keywords provided by Integrated Diagnostics:
Precancerous conditions
Carcinoma

Additional relevant MeSH terms:
Carcinoma
Precancerous Conditions
Multiple Pulmonary Nodules
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014