Page 11 - Delaware Medical Journal - July 2017
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INI-001:
PROTOCOL OF THE MONTH
Prospective observational multicenter study to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced non-small cell lung cancer.
CANCER PROTOCOL
Primary Objective:
The primary objective of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-small cell lung cancer (NSCLC).
Secondary Objectives:
matched tissue analysis.
Exploratory Objectives:
To evaluate the feasibility of the Inivata liquid biopsy testing in clinical practice.
To explore the relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata
liquid biopsy assay.
Eligibility Criteria:
Inclusion Criteria:
Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous non-small cell lung cancer (NSCLC).
stereotactic radiosurgery (no whole-brain radiotherapy).
Exclusion Criteria:
Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy.
Patients who have had any other prior metastatic or have current second primary cancer.
Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may
Registration:
ARM A: Baseline: Blood + Tissue + Data Collection THEN at 6 Months Only Data Collection ARM B: Baseline: Blood + Data Collection
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-744-1040 for more information.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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