Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
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|ClinicalTrials.gov Identifier: NCT03236675|
Recruitment Status : Unknown
Verified February 2019 by Exosome Diagnostics, Inc..
Recruitment status was: Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : February 15, 2019
|Condition or disease|
|Carcinoma, Non-Small-Cell Lung|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
ALK positive patients
T790M positive patients
- ALK mutation by tissue assay. [ Time Frame: Two years ]Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
- T790M EGFR mutation by tissue assay [ Time Frame: Two years ]Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
Biospecimen Retention: Samples Without DNA
10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired via standard venipuncture.
This will be an observational study as subjects will only provide plasma specimens at different time points and no therapeutic or intervention will be received outside of their normal standard of care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236675
|United States, Florida|
|Memorial Healthcare System|
|Hollywood, Florida, United States, 33021|
|United States, Louisiana|
|Ochsner Medical Center|
|New Orleans, Louisiana, United States, 70121|
|Study Director:||Roger Tun||Exosome Diagnostics, Inc.|