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临床试验/NCT02301858
NCT02301858Unknown不适用

Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

Janna Berg1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung

研究概览

简要总结

The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.

详细描述

The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with metastasizing lung cancer where further treatment is still applicable.

排除标准

  • •Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
  • •Patients where further cancer treatment is no longer applicable.
  • •Patients with cognitive impairment.
  • •Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.

研究组 & 干预措施

Study arm

Other

Genome analysis of tissue samples.

干预措施: Genome analysis of tissue samples. (Genetic)

结局指标

主要结局

Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung

时间窗: 5 years

We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations. Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.

次要结局

未报告次要终点

研究者

发起方
Janna Berg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Janna Berg

Consultant

Sykehuset i Vestfold HF

研究点 (1)

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