Status:
COMPLETED
Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Cardiff Oncology
Conditions:
Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- lung cancer and colorectal cancer
- Comorbidities that would prohibit or make serial urine collection difficult or impossible
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02186236
Start Date
July 1 2014
Last Update
September 27 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering West Harrison
East White Plains, New York, United States, 10604
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065