Identification of a Plasma Proteomic Signature for Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - Any
Updated:2/7/2015
Start Date:October 2012
End Date:December 2015
Contact:Adam Callahan
Email:acallahan@indidx.com
Phone:206-576-6324

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The primary objective is to identify a panel of plasma and/or serum proteins that
differentiates the absence or presence of lung malignancy in samples obtained from subjects
enrolled in this IRB/EC approved study with pulmonary nodules.

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:
≥M1
We found this trial at
12
sites
Burlington, Massachusetts 01805
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Anniston, GA
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Baltimore, MD
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Miami, FL
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Murray, Utah 84107
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Murray, UT
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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San Francisco, California 94115
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San Francisco, CA
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Seattle, Washington 98101
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Seattle, WA
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