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What Benefit of a Full Analysis of Exome? Routine Care Study in Patients With Solid Tumors (EXOMA)

2019年11月19日 更新者:Centre Georges Francois Leclerc

The management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. These molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. But these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known.

These therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. Now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials Phase 1 to 3.

In recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. Indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). Thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. Targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. An analysis of tumor exome by next-generation sequencing (NGS) and provides information on genetic modifications of these tumors.

This study did not aim to evaluate a therapeutic strategy or treatment. The objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the Centre Georges-François Leclerc from Dijon. The analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

795

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

      • Dijon、法国、21079
        • CGFL

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 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

patient with all types of solid malignant tumors not treatable metastatic

描述

Inclusion Criteria:

  • over 18 years
  • histological and cytological diagnosis of solid evidence of malignancy metastatic or locally advanced non-curable and non-curable
  • Disease for which a treatment under the national standards do not exist or will not exist if it escapes the current treatment
  • Availability of equipment or new tumor biopsy / puncture a feasible accessed injury (biopsiable disease), only if it is deemed necessary in the treatment by the investigator.
  • Patient affiliated with a social security scheme
  • Patient non opposition

Exclusion Criteria:

  • No tumor material available for the establishment of the tumor profile.
  • Patient refusal
  • Psychiatric illness and / or patient condition compromising the understanding of the information or the conduct of the study
  • Patient under guardianship or subject to major people protection regime

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

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
patient with all types of solid malignant tumors not treatable
In the treatment or assessment of metastatic solid tumor malignancies not curable it can be offered to patients to establish the profile of their tumor by next generation sequencing (NGS). This technique permits the sequencing of millions of fragments in parallel in a short time and allows to identify rapidly somatic or constitutional mutations known or yet unknown. The establishment of the genetic profile of the tumor coupled to the available clinical data can help clinicians to predict patient outcome in terms of survival or progression to disease, but may also provide key clues to adapt the management and patient treatment.

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
Feasibility of exome analysis for patient with a malignant solid tumors
大体时间:1 month
Feasibility assess by whether or not the patient will have targeted therapeutic
1 month

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 (实际的)

2016年5月15日

初级完成 (实际的)

2016年5月15日

研究完成 (实际的)

2019年4月29日

研究注册日期

首次提交

2016年7月19日

首先提交符合 QC 标准的

2016年7月19日

首次发布 (估计)

2016年7月21日

研究记录更新

最后更新发布 (实际的)

2019年11月20日

上次提交的符合 QC 标准的更新

2019年11月19日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • EXOMA

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