NL-OMON56674尚未招募3 期
IVD1: Clinical Performance Study Plan For The Use of Myriad MyChoice® For Patient Enrolment Into the AZD5305 (Saruparib) vs Placebo in Participants with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician*s Choice New Hormonal Agents;IVD2: Clinical Performance Study Plan for F1LCDx Used in Clinical Trial EvoPAR-Prostate01 ;Main: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician*s Choice New Hormonal Agents in Patien - EvoPAR-Prostate01
Astra Zeneca0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
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
- •- Provision of a FFPE tumour tissue sample and a blood sample (for ctDNA) as
- •- FFPE samples from primary or metastatic sites.
- •- Archival or newly acquired FFPE tumour tissue samples are permitted provided
- •they are taken as part of routine clinical practice.
- •- Specimens must be either a solid tumour prepared as an FFPE block or FFPE
- •slide sections that are 4-5 microns thick.
- •- 2 x 10mL Streck Cell-Free DNA BCT collection tubes of whole blood must be
- •submitted prior to study enrollment for testing with F1LCDx.
- •- Samples to be provided prior to starting ADT, if possible.
- •- To ship as soon as possible after collection within the 14 days stability
- •window at temperature range of 6°C to 37°C.
排除标准
- •- Tumour Content (<20%)*.
- •- Number of slides (<21)*.
- •- Stained or broken slides.
- •- Bone metastasis samples with acid decalcification treatment, brain metastasis
- •and central nervous system metastasis.
- •- Specimen taken from previously irradiated lesion.
- •* if a sample does fall below these levels, the site should contact the
- •AstraZeneca study team for advice before excluding the sample.
- •- Tissue, other liquid samples besides whole blood are excluded.
- •- Samples yielding plasma volume <2.5mL.
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