Identification of a Plasma Proteomic Signature for Lung Cancer

Completed

Conditions studied: Precancerous Conditions, Carcinoma

In brief

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.

Key facts

Study ID

NCT01752101

Run by

Integrated Diagnostics

People needed

475

Starts

2012-10-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente Northern California — San Francisco, California, United States
• University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• North East Alabama Regional Medical Center — Anniston, Georgia, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Cardiopulmonary Research Science and Technology Institute — Dallas, Texas, United States
• Intermountain Healthcare — Murray, Utah, United States
• Group Health Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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