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临床试验/NCT05818865
NCT05818865进行中(未招募)不适用

"Principle Test" for Isolation and Characterization of Cancer Cells (CTC)-CXCR4+ Circulating in Belotero Loaded With CXCL12 in Patients With Solid Neoplasms (Endometrium, Kidney, Glioblastoma, Colorectal, Ovary and Lung).

National Cancer Institute, Naples4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
47
试验地点
4
主要终点
In vitro isolation of CTCs.

研究概览

简要总结

This is multicentric, interventional, non farmacological and prospective study.

详细描述

The new CLG platform, a prototype owned by IRCCS Pascale Institute, is able to reconstruct a PMN for the capture of CTCs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. The purpose of the study is to evaluate in vitro the effectiveness of CLG in the isolation, recovery and subsequent molecular characterization of CTCs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Signature of Informed Consent
  • Advanced solid neoplasm with metastases

排除标准

  • Refusal to sign informed consent

结局指标

主要结局

In vitro isolation of CTCs.

时间窗: 2 years

In vitro isolation of CTCs with high metastatic capacity from peripheral blood through CLG.Gene expression analysis will be performed using 250ng RNA for nCounter FLEX Analysis System (NanoStringTechnologies). Panels analyzed include the PanCancer Pathways and the PanCancer Progression. The data will be analyzed using the nSolver analysis software version 3.0

Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers

时间窗: 2 years

Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR.

次要结局

  • The correlation of the number and of biological/molecular characteristics of CTCs with the clinical/pathological characteristics of the patients in analysis and their prognosis.(2 years)

研究者

发起方
National Cancer Institute, Naples
申办方类型
Other
责任方
Sponsor

研究点 (4)

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