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

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ClinicalTrials.gov Identifier: NCT02186236
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Trovagene, Inc.
Information provided by (Responsible Party):
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.

Condition or disease
Lung Cancer Colorectal Cancer

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients
Study Start Date : July 2014
Actual Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. EGFR detection in urinary cell free DNA [cfDNA] [ Time Frame: 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

  2. To validate the Trovagene urine assay [ Time Frame: 2 years ]
    urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.


Secondary Outcome Measures :
  1. EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA) [ Time Frame: 2 years ]
    The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.


Biospecimen Retention:   Samples With DNA
periphera blood sample and urine sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC clinics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186236


Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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, 10591
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States, 10604
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Trovagene, Inc.
Investigators
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Principal Investigator: Helena Yu, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02186236     History of Changes
Other Study ID Numbers: 14-114
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Detection of Oncogenic Tumor Mutations
blood
urine
14-114

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases