NL-OMON56968尚未招募3 期
A clinical performance study for testing FFPE tissue samples, with therascreen® KRAS RGQ PCR kit, to determine KRAS G12C mutation for potential enrollment into clinical study BO45217 - Performance study: KRAS G12C mutation for enrollment into study BO45217
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 23
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
- •Tissue inclusion / exclusion criteria: Tumor specimens will be formalin-fixed,
- •paraffin-embedded (FFPE) in a paraffin block (preferred) or 10-15 (15
- •preferred) unstained, freshly cut, serial slides and should be of good quality,
- •with a minimum of 500 viable tumor cells. Samples collected via resection, core
- •needle biopsy, excisional, incisional, punch, or forceps biopsy, or
- •endobronchial ultrasound (EBUS)-transbronchial needle aspiration are
- •acceptable. Samples that do not preserve tissue architecture, including
- •fine-needle aspiration, brushing, cell pellets from pleural effusion, and
- •lavage samples are not acceptable. Tumor tissue from bone metastases that have
- •been decalcified is not acceptable.
- •Details on the inclusion criteria of the study subjects are described in
- •Section 5.1 of the clinical trial protocol for BO45217
排除标准
- •Details on the exclusion criteria of the study subjects are described in
- •Section 5.1 of the clinical trial protocol for BO45217
研究者
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