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Validation of Molecular Biomarkers for the Early Detection of Lung Cancer in the setting of Indeterminate Pulmonary Nodules (Lung Team Project #2)

Spira, AvrumBoston University
1) a multi-gene mRNA biomarker measured in cytologically normal large airway epithelial cells identified using genome-wide gene-expression profiling, 2) proteomic profiles measured in bronchial airway epithelial cells, 3) serum glycan antibody signature, 4) hypermethylated sites found in promoter regions of tumor suppressor genes measured in blood, 5) cytokines and growth factors secreted from the tumor microenvironment measured in peripheral blood, and 6) two distinct circulating miRNA signatures measured in the serum and plasma
Lung and Upper Aerodigestive Cancers Research Group

The goal of this collaborative group study is to improve the diagnostic evaluation of patients with indeterminate pulmonary nodules by determining whether molecular biomarkers for lung cancer diagnosis, measured in minimally invasive and non-invasive biospecimens, are able to distinguish between patients with malignant or benign indeterminate pulmonary nodules that are incidentally detected on CT scan in high risk smokers. Achieving this goal would suggest that these biomarkers could also be applied in the setting of indeterminate pulmonary nodules that are detected as part of radiographic screening for lung cancer. Sensitive and specific biomarkers that discriminate between patients with malignant or benign indeterminate pulmonary nodules could spur early treatment and thereby improve lung cancer outcomes, while minimizing complications from diagnostic procedures in patients without lung cancer. Thus, this collaborative group proposal seeks to validate a series of molecular biomarkers (including mRNA, miRNA and proteomic signatures in the airway and blood) that have been developed by EDRN lung cancer investigators as effective diagnostic tools of lung cancer for patients with indeterminate pulmonary nodules

3.1.1   Aim 1 Establish a cohort (n=200) of current and former smokers with indeterminate pulmonary nodules (7mm-25mm) on whom clinical, radiographic and biospecimen repositories are developed and who are followed prospectively until final diagnosis. 3.1.2   Aim 2 Validate the diagnostic accuracy of existing molecular biomarkers in the airway and blood to detect lung cancer in this clinical cohort.
Airway gene-expression biomarker (BU) Airway protein biomarker (VU): LC-MRM-MS analyses Serum glycan biomarker (NYU): Plasma promoter methylation biomarker (JHU): Serum cytokines biomarker (UCLA): Serum/Plasma miRNA biomarker (OSU): Plasma miRNA biomarker (UMD):

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.

2015 Steering Committee Meeting

The next EDRN Steering Committee Meeting will take place March 31st through April 2nd, 2015, in Atlanta, Georgia.

Announcement 12/02/2014

New Round of EDRN FOAs

The RFAs for EDRN have been released:
- Biomarker Developmental Laboratories (U01),
- Clinical Validation Centers (U01),
- Biomarker Reference Laboratories (U24),
- Data Management and Coordinating Center (U24).

EDRN Renewal flyer NOTE-New receipt deadline for applications submitted for all EDRN FOAs is January 20, 2015, by 5:00 PM local time of applicant organization.

There will be a Pre-Application webinar to discuss each of the four individual EDRN FOAs on Tuesday, December 2nd, 2014, from 1pm-5pm (Eastern). Potential applicants interested in participating in the webinar should send a message to Dr. Sharmistha Ghosh ( no later than 5:00 p.m. (EST) November 21, 2014. Please mention the FOA of interest in the subject line.

Announcement 10/07/2014

EDRN Patient Advocates will host an EDRN Advocacy Educational Webinar, Biomarkers for Prostate Cancer Detection and Monitoring, on Monday, January 12th, 2015, at 1 p.m. EDT / 10 a.m. PDT. Registration is not required for this. Please click for more information.