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临床试验/NCT01247467
NCT01247467Unknown不适用

Analysis of Prognostic and Predictive Genomic Signatures Using Archival Paraffin-embedded Breast Tumor - a Pilot Study

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1

研究概览

简要总结

A number of prognostic and/or predictive genomic signatures for breast cancer have been developed by Genome Institute of Singapore (GIS). In the past 1 year, GIS has developed protocols and methods to conduct expression assays from formalin-fixed, paraffin-embedded (FFPE) tumor specimens. A study on 800 tumor samples is planned to analyze these gene signatures and compare them with conventional clinical prognosticators and predictors. As the investigators plan to use archival tumor samples that dates back to the 1990s, the aim of this pilot study is to first analyze 10 anonymized samples to determine the feasibility of running these assays on old archival blocks. The information generated will help us determine whether very old samples (diagnosed before 2000) may be selected for the actual study.

详细描述

Up to 10 archival breast tumor blocks will be obtained from the Department of Pathology, NUH - half of these blocks will be from patients who were diagnosed before year 2000, and the other half of the blocks will be from patients diagnosed between year 2000-2005 (control specimens). Basic tumor and patient information will be collected without patient identifiers - grade, stage, ER/PR/HER2 status, treatment received, outcome data. 8-10 ten-micron sections will be cut from each tumor block. RNA will be extracted from the tumor sections using the Roche High Pure FFPE RNA Micro Kit. RNA will be profiled using the Illumina Veracode assay and the Affymetrix Quantigene assay. RNA extraction and gene expression profiling will be performed by collabroators at the Genome Institute of Singapore.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Half of these blocks will be from breast cancer patients who were diagnosed before year
  • Half of the blocks will be from breast cancer patients diagnosed between year 2000-2005 (control specimens).

排除标准

  • Breast cancer patients diagnosed after year 2005.

研究者

申办方类型
Other

研究点 (1)

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