肿瘤细胞治疗研究
英文原题：Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy
本检测服务评估既往接受百时美施贵宝（BMS）生产的基因修饰细胞治疗、随后发生符合检测条件第二原发恶性肿瘤患者的肿瘤样本转基因水平。
不限性别
纳入标准： • 参加者曾接受BMS生产的商业化基因修饰细胞治疗（GMCT），并被诊断为符合检测条件的第二原发恶性肿瘤，或BMS已认定符合检测条件的第二原发恶性肿瘤。 • 参加者曾在临床试验或其他研究性治疗环境中接受BMS生产的商业化GMCT（包括不符合规范的产品），且该试验/研究性环境没有现行检测方案；同时被诊断为符合检测条件的第二原发恶性肿瘤，或BMS已认定符合检测条件的第二原发恶性肿瘤。 排除标准： • 参加者正在参加另一项临床试验，且该试验正在收集相关信息和样本。 • 参加者未接受BMS生产的GMCT，或未被诊断为符合检测条件的第二原发恶性肿瘤。
Inclusion Criteria: * Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing. * Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing. Exclusion Criteria: * Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial. * Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results · Baseline；Participant insertion site analysis (ISA) testing results · For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene · Baseline
本转基因检测服务旨在对肿瘤样本进行检测，评估转基因水平。检测对象为既往接受百时美施贵宝（BMS）商业化基因修饰细胞治疗、且报告发生符合检测条件的第二种恶性肿瘤的患者。
The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.
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