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Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

50 Years
Open (Enrolling)
Precancerous Conditions, Carcinoma

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Trial Information

Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

Patients must present with previously non-diagnosted 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

Inclusion Criteria:

- Age ≥ 50 years

- Smoking history ≥ 20 pack-years

- 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

- Nodules 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer

Outcome Description:

Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.

Outcome Time Frame:

2 years post enrollment

Safety Issue:


Principal Investigator

Kenneth Fang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Integrated Diagnostics, Inc.


United States: Quorum Review IRB

Study ID:




Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Precancerous Conditions
  • Carcinoma
  • Precancerous conditions
  • Carcinoma
  • Carcinoma
  • Precancerous Conditions



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