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Identification of a Plasma Proteomic Signature for Lung Cancer

40 Years
Open (Enrolling)
Precancerous Conditions, Carcinoma

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Trial Information

Identification of a Plasma Proteomic Signature for Lung Cancer

Blood samples are obtained from those patients undergoing procedures to determine if a lung
nodule is benign or cancerous. The data from the study will not be used to guide or
influence the treatment of the patients enrolled in this study. There is no change from the
normal standard of care that patients receive.

Inclusion Criteria:

- age ≥ 40

- any smoking status, e.g. current, former, or never

- co-morbid conditions, e.g. COPD

- Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground
glass opacity

- Pathology: malignant - adenocarcinoma, squamous, or large cell

- Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory
(e.g. hamartoma)

- Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)

- Clinical stage, Regional lymph nodes: N0 or N1 only

- Clinical stage, Distant metastasis: M0 only

Exclusion Criteria:

- prior malignancy within 5 years of lung nodule diagnosis

- No nodule size available

- No pathology data available for those with

- Current diagnosis of non-small cell lung cancer

- Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis:

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Incidence rate of Non-Small Cell Lung Cancer

Outcome Description:

The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.

Outcome Time Frame:

24 months after enrollment

Safety Issue:


Principal Investigator

Ken Fang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Integrated Diagnostics, Inc.


United States: Quorum Review IRB

Study ID:




Start Date:

October 2012

Completion Date:

August 2013

Related Keywords:

  • Precancerous Conditions
  • Carcinoma
  • Precancerous Conditions
  • Carcinoma
  • Carcinoma
  • Lung Neoplasms
  • Precancerous Conditions



Mayo Clinic Rochester, Minnesota  55905
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Henry Ford Hospital Detroit, Michigan  48202
Greater Baltimore Medical Center Baltimore, Maryland  21204
University of Cincinnati Cincinnati, Ohio  45267-0502
Group Health Research Institute Seattle, Washington  98101
Kaiser Permanente Northern California Oakland, California  94612
Intermountain Healthcare Salt Lake City, Utah  84103
North East Alabama Regional Medical Center Anniston, Georgia  36207
Lahey Hospital & Medical Center Burlington, Massachusetts  01805
Cardiopulmonary Research Science and Technology Institute Dallas, Texas  75230