Clinical trial NCT02186236: Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients
Official title: A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Colorectal Cancer
Keywords: Detection of Oncogenic Tumor Mutations
blood
urine
14-114
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Cardiff Oncology
First posted: 2014-07-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

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.


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.

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 Criteria:

lung cancer and colorectal cancer

* Comorbidities that would prohibit or make serial urine collection difficult or impossible

Primary outcomes:
measure: EGFR detection in urinary cell free DNA [cfDNA]
timeFrame: 2 years
measure: To validate the Trovagene urine assay
timeFrame: 2 years
Secondary outcomes:
measure: EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center at Phelps
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Helena Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: