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Report for Clinical Trial NCT03236675

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

NCT03236675 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma


Primary Outcomes

Description: 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.

Measure: ALK mutation by tissue assay.

Time: Two years

Description: 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.

Measure: T790M EGFR mutation by tissue assay

Time: Two years

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 T790M

Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients. --- T790M ---

Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients. --- T790M ---

Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients. --- T790M --- --- T790M ---

2x2 table will be constructed to determine concordance with tissue testing.. T790M EGFR mutation by tissue assay. --- T790M ---

Patients found to be positive for T790M EGFR mutation by tissue assay. --- T790M ---

Exclusion Criteria: 1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin < 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue Inclusion Criteria: 1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay. --- T790M ---

Exclusion Criteria: 1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin < 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue Carcinoma, Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay. --- T790M ---

Exclusion Criteria: 1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin < 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue Carcinoma, Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay. --- T790M --- --- T790M ---

Exclusion Criteria: 1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin < 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue Carcinoma, Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay. --- T790M --- --- T790M --- --- T790M ---



HPO Nodes


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