DSP-DE-MS-14-009
Research type
Research Study
Full title
A Study to determine the concordance of key actionable genomic alterations as assessed in tumour tissue and plasma from patients with non-small cell lung carcinoma (NSCLC)
IRAS ID
212775
Contact name
Sandra Gumy
Contact email
Sponsor organisation
Genomic Health
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 4 days
Research summary
The primary purpose of this study is to assess concordance of genomic alterations of clinical relevance in EGFR (Epidermal Growth Factor Receptor) detected in plasma versus tumour tissue in patients with stage IV non-small cell lung carcinoma (NSCLC) who are newly diagnosed or progressing on treatment. Tissue biopsy of a metastatic lesion or primary lesion with stage IV presentation at diagnosis and blood collection (liquid biopsy) should be less than six weeks apart and with no new systemic antitumoural treatment given in the interval between the tissue and liquid biopsies. The Genomic Health Next Generation Sequencing Liquid Biopsy Mutation Panel (LBMP) is currently classified as a Laboratory Developed Test (LDT) System. The test has been developed to detect clinically relevant genomic alterations in blood (plasma). This clinical concordance study is designed to yield results that support clinical use of the LBMP. The study plan is to enrol approximately 213 patients with stage IV non-small cell lung carcinoma (NSCLC).
Approximately 25 USA and International centres are participating including centres in France, Germany, Ireland, Spain, United Kingdom and Japan.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0032
Date of REC Opinion
24 Mar 2017
REC opinion
Further Information Favourable Opinion