CTIS2023-508830-33-00招募中1 期
HER2-PREDICT: Translational study of tumor samples from patients treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a) - SOLTI-1804
Solti Group0 个研究点目标入组 180 人开始时间: 2023年12月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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 65+（—）
入选标准
- •Women and men =18 years old who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan (T-DXd; DS-8201a) as a treatment for metastatic/advanced cancer., The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart., Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content.a.Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases. b.Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable., Patients included before starting experimental treatment must be able and willing to provide blood sample(s).
排除标准
- •Not applicable
研究者
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