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临床试验/NCT06449989
NCT06449989招募中不适用

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer

Blokhin's Russian Cancer Research Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Concordance rate (%)

研究概览

简要总结

GENCONCOR-1 study is translational research aimed to investigate the concordance of the molecular genetic profile of the primary tumor and brain metastases (BM) of colorectal cancer (CRC). The study was conducted by post hoc analysis of pairs of samples of histological material with determination of the mutational status of genes KRAS, NRAS, BRAF, HER2 and MSI.

详细描述

Brain metastases (BM) from colorectal cancer (CRC) are a rare event reported in less than 3% of patients with CRC (the reported incidence ranges from 0.27 to 3%). This course is associated with a poor prognosis. Treatment of these patients remains challenging. Nevertheless, given the rarity of the event, at this time not enough is known about molecular biology of BM from colorectal cancer and its concordance with matched primary tumors.

In N.N. Blokhin National Medical Research Center of Oncology over 26 years (1998-2024) identified 108 patients with BM from CRC. Of this number, 72 patients had a history of neurosurgical resection of BM. In turn, for 32 patients access to a pair of tumor samples: from the primary tumor and from intracranial metastases. Tumor samples will be tested for mutation status of genes KRAS, NRAS, BRAF, HER2 and MSI. Analysis was limited to this pool of genes because of their clinical relevance and potential prognostic information. The molecular profile of the BM will be compared with the corresponding primary tumor with calculation of concordance rate (%).

研究设计

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

入排标准

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

入选标准

  • Men and women over 18 years of age.
  • Histologically confirmed cancer of the colon or rectum.
  • Histologically confirmed metastatic lesion of the brain.
  • Neurosurgical resection for brain metastases of colorectal cancer.
  • Presence of paired tumor samples (both primary tumor and intracranial material).

排除标准

  • Missing one sample from a pair of tumor samples.
  • Low quality or lack of tumor material for molecular genetic research.

结局指标

主要结局

Concordance rate (%)

时间窗: 1 month

Concordance rate (%) between mutational status of the brain lesions and their corresponding primary tumor. Calculated as the ratio of concordant cases to total cases.

次要结局

  • Intracranial progression-free survival (CNS-PFS1)(3 months)
  • Overall survival (OS)(6 months)
  • Intracranial progression-free survival (CNS-PFS2)(3 months)

研究者

发起方
Blokhin's Russian Cancer Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Halafyan

Physician-researcher

Blokhin's Russian Cancer Research Center

研究点 (1)

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