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

NCT02186236 | Completed

• 1 other identifier: 14-114
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 6

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.

Conditions

Lung Cancer; Colorectal Cancer

Keywords

Detection of Oncogenic Tumor Mutations; blood; urine; 14-114

Outcome Measures

Primary Outcomes (2)

• EGFR detection in urinary cell free DNA [cfDNA]

  The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer

  2 years

• To validate the Trovagene urine assay

  urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.

  2 years

Secondary Outcomes (1)

• EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)

  2 years

Study Arms (1)

Lung and Colorectal cancer patients

Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• 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

You may not qualify if:

• lung cancer and colorectal cancer
• Comorbidities that would prohibit or make serial urine collection difficult or impossible

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Cardiff Oncology: collaborator

Study Sites (6)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

East White Plains, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memoral Sloan Kettering Cancer Center at Phelps

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

periphera blood sample and urine sample

MeSH Terms

Conditions

Lung Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Helena Yu, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

US (6)