Lung Cancer Clinical Trial

Identification of a Plasma Proteomic Signature for Lung Cancer

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

475

Study ID:

NCT01752101

Recruitment Status:

Completed

Sponsor:

Integrated Diagnostics

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There are 12 Locations for this study

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Kaiser Permanente Northern California
San Francisco California, 94115, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
North East Alabama Regional Medical Center
Anniston Georgia, 36207, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01805, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Mayo Clinic
Rochester Minnesota, 55901, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Cardiopulmonary Research Science and Technology Institute
Dallas Texas, 75230, United States
Intermountain Healthcare
Murray Utah, 84107, United States
Group Health Research Institute
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

475

Study ID:

NCT01752101

Recruitment Status:

Completed

Sponsor:


Integrated Diagnostics

How clear is this clinincal trial information?

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