跳至主要内容
临床试验/NL-OMON56986
NL-OMON56986尚未招募不适用

Clinical Performance Study Protocol for Use of VENTANA PD-L1(SP263) CDx Assay in GSK Study 213823 (GALAXIES LUNG-301) - GSK GALAXIES LUNG-301 PD-L1

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • To be included in this Dx protocol, a specimen must meet all of the following
  • 1. It must be a formalin-fixed, paraffin embedded (FFPE) tumor
  • specimen submitted for central PD-L1 testing for the GALAXIES
  • LUNG-301 Study and processed in accordance with standard
  • 2. It must contain sufficient tumor tissue for interpretation at the
  • discretion of the reviewing pathologist; and
  • 3. If an FFPE tissue block is unavailable, unstained FFPE slides can be

排除标准

  • A specimen will be excluded from the Dx protocol if any of the following
  • criteria are true:
  • 1. It is known to be fixed in 95% alcohol, alcohol-formalin-acetic acid
  • (AFA), or PREFER;
  • 2. It is a fine needle aspirate (FNA), cytology, bone marrow or bone
  • 3. It consists of tissue containing bone that has been decalcified*; or
  • 4. Cut slides were prepared more than 12 months prior to staining.
  • *Prior to testing any specimen, evidence of decalcification must be
  • obtained.This information may
  • be obtained from the pathology report. If the pathology report is not available
  • or does not specify
  • whether the sample was decalcified or not, the sample must be held and the
  • submitting site
  • queried. If the sample has been decalcified, testing cannot proceed.

研究者

发起方
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

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