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

2016年9月26日 更新者:Memorial Sloan Kettering Cancer Center

A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

84

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • Basking Ridge、New Jersey、美国
        • Memoral Sloan Kettering Cancer Center
    • New York
      • Commack、New York、美国、11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre、New York、美国
        • Memorial Sloan Kettering at Mercy Medical Center
      • Sleepy Hollow、New York、美国、10591
        • Memoral Sloan Kettering Cancer Center at Phelps
      • West Harrison、New York、美国、10604
        • Memorial Sloan Kettering West Harrison

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

MSKCC clinics

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
EGFR detection in urinary cell free DNA [cfDNA]
大体时间: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 years
To validate the Trovagene urine assay
大体时间:2 years
urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.
2 years

次要结果测量

结果测量
措施说明
大体时间
EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)
大体时间:2 years
The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年7月1日

初级完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2014年7月7日

首先提交符合 QC 标准的

2014年7月7日

首次发布 (估计)

2014年7月10日

研究记录更新

最后更新发布 (估计)

2016年9月27日

上次提交的符合 QC 标准的更新

2016年9月26日

最后验证

2016年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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