CEEOG projects

CLOVIS CO-1686-006 - A prospective study to evaluate the concordance of tumor-associated mutations detected in matched tumor and blood samples in patients with NSCLC with known epidermal growth factor receptor mutational status

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Study team:

Chief Investigator: Rafał Dziadziuszko, MD, PhD

Sponsor:

CLOVIS

Study Coordinator:

Alicja Maciejewska-Izdebska MSc, CEEOG

Study title:

A prospective study to evaluate the concordance of tumor-associated mutations detected in matched tumor and blood samples in patients with NSCLC with known epidermal growth factor receptor mutational status

Start date:

01 December 2011

Study status:

Closed

Background:

Study is designed to prospectively collect matched blood and tumor tissue from NSCLC patients with known EGFR mutation status. Eligible patients will undergo clinically indicated biopsy procedures. Specimen will be sent to central laboratory where DNA extracted from FFPE tumor tissue will be analyzed for all major EGFR mutations and compared to DNA isolated from matched blood samples (plasma and serum) to determine accordance. Limited clinical information on enrolled patients will be collected where available and will enclude demographics, data of initial diagnosis, date/type/duration of treatment administered, best overall response to each therapy, date if initial and subsequent biopsy and methodology/results of molecular characterization of tumor.