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临床试验/NCT03888638
NCT03888638已完成不适用

Search for the Clinical Significance of Tumor-associated Macrophages in Patients With Colorectal Liver Metastases

Humanitas Clinical and Research Center0 个研究点目标入组 101 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
主要终点
Survival

研究概览

简要总结

Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Nevertheless, in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients. Tumor-associated macrophages (TAMs) pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases. The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression, and the quantification of TAMs might explain the heterogeneity of CLM patients. Here, we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients. This will open new clinical scenarios both for the diagnosis, therapy and prognosis, leading to the refinement of the therapeutic output in a personalized medicine perspective.

详细描述

Some preliminary data produced by the research team from Humanitas Clinical and Research Center in Milan (ITALY) have shown that TAMs in CLM are heterogeneous and that their diversity can be distinguished based on their morphology and functionality. Therefore, TAMs may represent an additional tool in the definition of the biology and prognosis of CLM patients. This preliminary finding provides us with the rationale to undertake a prospective study on a large series of CLM patients surgically resected by our unit aimed at validating the promisingcorrelation between different TAMs phenotypes and patients prognosis. The characterization of the diversity of TAMs in CLM will be refined using state of the art technology, including multi-parametric flow cytometry, single cell RNA sequencing (scRNA-seq) transcriptional profiling, metabolomic, and proteomic analyses. The expected findings will allow us to develop a new diagnostic tool based on TAMs features, which will open the way to new criteria for patient stratification and for the design of new targeted therapies in a personalized medicine perspective.

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

  • Patients with colorectal liver metastases undergoing hepatectomy
  • Full clinical, surgical, pathological and follow-up data
  • Availability of tissues for the analysis

排除标准

  • Missing (any) data
  • Combination of radiofrequency or microwave ablation plus surgery

结局指标

主要结局

Survival

时间窗: From date of surgery until the date of first documented progression or date of death from any cause, which ever came first assessed up to 72 months]

Analysis of survival after hepatic resection for colorectal liver metastases according with the tumor-associated macrophages characteristics

次要结局

未报告次要终点

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Donadon

Assistant Professor of Surgery

Humanitas Clinical and Research Center

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