NL-OMON56824尚未招募不适用
Clinical Performance Study Plan for FoundationOne®CDx Used as a Clinical Trial Assay in Clinical Trial PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours That are MTAP Deficient - Clinical Performance Study Plan for F1CDx in Clinical Trial PRIMROSE
Astra Zeneca0 个研究点目标入组 11 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
- 11
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
- •Primary Specimen ID and Subject ID accompanying sample
- •Optimal tissue volume of at least 0.6 mm3 or absolute minimum tissue volume
- •of 0.2 mm3
- •Final percent tumor nuclei of at least 20% (optimally 30% or greater)
- •Sufficient cellularity - determined by Foundation Medicine, Inc. pathologist
- •discretion.
- •Archival or newly collected FFPE tumor samples from the most recently
- •collected tumor tissue sample, derived from the primary or recurrent cancer
- •FFPE specimens, including tumor resections and core needle biopsies.
- •10 x 4 micron sections on positively charged slides, minimum of 3 consecutive
- •Slides sectioned within 12 months.
- •Recommended FFPE block size is 25 mm x 25 mm
排除标准
- •Fine-needle aspirates (FNA) and effusion cytology samples/other sample types
- •agreed with study team are NOT accepted.
- •Specimens from metastatic bone lesions are unacceptable.
- •Sample is fixed in anything other than 10% NBF (e.g. Bouins, B5, Holland*s,
- •zinc buffered formalin).
- •Slides sectioned over 12 months.
- •Baked samples above 37 degrees Celsius.
- •Blocks larger than 30 x 25 mm cannot be processed.
研究者
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