CompletedNot applicableNCT02186236
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLung Cancer · Colorectal Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 27, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion criteria
  • lung cancer and colorectal cancer
  • Comorbidities that would prohibit or make serial urine collection difficult or impossible

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey
  • Memorial Sloan Kettering Cancer Center @ SuffolkCommack, New York
  • Memorial Sloan Kettering West HarrisonEast White Plains, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering at Mercy Medical CenterRockville Centre, New York
  • Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 27, 2016. Always confirm current availability with the study team.

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