NL-OMON53260尚未招募不适用
Prospective Clinical Utility Study for the NaPi2b (67) Assay in Serous Ovarian Cancer - TSUNAMI UP-NEXT Clinical Utility Study Protocol
eica Biosystems Newcastle0 个研究点目标入组 12 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
- 12
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
- •FFPE tissue block or at least 3 FFPE tissue slides (1 for detecting NaPi2b
- •status, 1 for negative rabbit control, and 1 slide for H&E assessment) of 4-5
- •µm section thickness received from Mersana collection sites, collected
- •according to Mersana study MER-XMT-1536-3 (UP-NEXT).
- •Surgical resections or core needle biopsies (FFPE)
- •Tissue preparation must meet all slide/sectioning requirements as detailed
- •within the NaPi2b (67) Assay IFU and BOND User Manual:
- •Section Thickness (if slides): 4-5 µm
- •Slides: Positively Charged, Leica BOND-III Compatible
- •Fixative: Formalin Fixed
排除标准
- •Fine Needle Aspirate (FNA) and ascites samples prepared as FFPE cell blocks
- •Cytology specimens (FNA, ascites, cell block)
- •The specimen is collected at a site which is not covered under Mersana study
- •MER-XMT-1536-3 IRB/IEC review.
- •The specimen is a repeat specimen from a patient whose sample has already
- •been included in the study.
- •FFPE section thickness is not 4-5 µm
- •Slides are not positively charged or are incompatible with BOND-III
- •Tissue is not formalin-fixed
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