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

Completed

• Conditions: Lung Cancer; Colorectal Cancer

• Registration Number: NCT02186236
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Read More

Exclusion Criteria

lung cancer and colorectal cancer

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EGFR detection in urinary cell free DNA [cfDNA]	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	2 years	urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.

Secondary Outcome Measures

Name	Time	Method
EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)	2 years	The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.

Trial Locations

Locations (6)

Memorial Sloan Kettering West Harrison; 🇺🇸 West Harrison, New York, United States

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center at Phelps; 🇺🇸 Sleepy Hollow, New York, United States