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Report for Clinical Trial NCT02186236

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02186236 Lung Cancer Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine


Primary Outcomes

Description: The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer

Measure: EGFR detection in urinary cell free DNA [cfDNA]

Time: 2 years

Description: urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.

Measure: To validate the Trovagene urine assay

Time: 2 years

Secondary Outcomes

Description: The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.

Measure: EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)

Time: 2 years

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 L858R

- 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. --- L858R ---

- Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory. --- L858R ---



HPO Nodes


HPO: