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

Status:	Recruiting
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2014
Contact:	Helena Yu, MD
Phone:	646-888-4274

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

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.

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

We found this trial at

sites

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York

Phone: 646-888-4274

from

Sleepy Hollow, NY