跳至主要内容
临床试验/NCT01853345
NCT01853345已完成不适用

Individualized Cancer Therapy (iCAT) Recommendation for Patients With Recurrent, Refractory or High Risk Solid Tumors

Dana-Farber Cancer Institute5 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
5
主要终点
Frequency of a cancer causing actionable alteration and individualized treatment recommendation.

研究概览

简要总结

In this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. This is called tumor profiling. A panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. If there is, the experts will determine if there is a targeted drug available that could counteract this alteration. If there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. The results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.

详细描述

Some cancer-causing gene alterations (such as mutations or copy number alterations) are common or occur repeatedly in different types of cancers. For some of these alterations there are drugs, called targeted drugs that specifically counteract the alteration. In certain cancer types, these targeted drugs are very effective at fighting the cancer.

A tumor specimen that has been obtained previously or is planned to be obtained as part of clinical care will be used to perform tumor profiling. Additional procedures to obtain tumor will not be performed. An expert panel will review the results of the tumor profiling tests and determine whether a cancer-causing alteration is present and whether an individualized treatment recommendation can be made. If consent to sharing of the tumor profiling results and individualized treatment recommendation is provided then a study physician will discuss the profiling results and the individualized treatment recommendation with the primary oncologist. In addition, the primary oncologist will receive a letter detailing the tumor profiling results and the individualized treatment recommendation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of recurrent, refractory of high risk pediatric solid tumor (excluding brain tumor)
  • Histologic proof of malignancy at the time of diagnosis or recurrence
  • Sufficient tumor specimen available for profiling from diagnosis or recurrence, or surgery/biopsy planned for clinical care

排除标准

  • Brain tumors

结局指标

主要结局

Frequency of a cancer causing actionable alteration and individualized treatment recommendation.

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Janeway, MD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (5)

Loading locations...

相似试验