A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 84
- Locations
- 6
- Primary Endpoint
- EGFR detection in urinary cell free DNA [cfDNA]
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •lung cancer and colorectal cancer
- •Comorbidities that would prohibit or make serial urine collection difficult or impossible
Outcomes
Primary Outcomes
EGFR detection in urinary cell free DNA [cfDNA]
Time Frame: 2 years
The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer
To validate the Trovagene urine assay
Time Frame: 2 years
urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.
Secondary Outcomes
- EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)(2 years)