Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung Cancer Patients
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Detection of Oncogenic Tumor Mutations, blood, urine, 14-114
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The purpose of this study is to see whether gene mutations in lung cancers can be found in the urine or blood of lung 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 cancer cells, not the normal cells in your body.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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:

- Comorbidities that would prohibit or make serial urine collection difficult or impossible
Locations
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Helena Yu, MD - 646-888-4274
Start Date
July 2014
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page