Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.

Official Title
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A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

Conditions
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Lung Cancer, Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung cancer: For patients participating in Part A (initial testing) and Part B (serial testing): Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy. Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory. ≥ 18 years of age Specific to patients participating in Part B (serial testing): Patients must be planning to receive cancer care at Memorial-Sloan Kettering. Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory. Must be within 3 months of their diagnosis of metastatic lung cancer. Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol. Colorectal Cancer: For patients participating in Part A (initial testing) and Part B (serial testing): Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy. Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment). >18 years of age Specific to patients participating in Part B (serial testing): Patients must be planning to receive cancer care at Memorial-Sloan Kettering. Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory. Must be within 3 months of their diagnosis of metastatic colorectal cancer. Exclusion Criteria: lung cancer and colorectal cancer Comorbidities that would prohibit or make serial urine collection difficult or impossible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung and Colorectal cancer patients<br>Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGFR detection in urinary cell free DNA [cfDNA] | The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer | 2 years | 
| To validate the Trovagene urine assay | urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA) | The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detection of Oncogenic Tumor Mutations, blood, urine, 14-114