肿瘤细胞治疗研究
英文原题：Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
这是一项分期未标注的注册临床试验，评估细胞治疗用于白血病、多发性骨髓瘤、血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态：邀请入组。计划入组 1000 例。试验地点：美国 · 贝塞斯达（共 1 个中心）。登记号：NCT02473757。
不限性别 · ≥ 18 Years
纳入标准： • 曾在CAR-T细胞基因治疗方案中接受治疗。年龄≥18岁，因为儿童通常不参加CAR-T基因治疗研究。
* INCLUSION CRITERIA: * Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age \>= 18 years as children are generally excluded from CAR T-cell gene therapy studies.
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：To provide long term follow up of patients previously enrolled on treatment protocols in the NCI ETIB Branch. · List of long time adverse event frequency after Gene therapy drug · 15 years
曾在NCI外科分部CAR-T细胞基因治疗方案中接受治疗的受试者。
背景：基因治疗是利用基因治疗或预防疾病的一种方式。由于可能出现长期且无法预料的副作用，监管机构对此类治疗进行严格监测。美国国立卫生研究院（NIH）须在基因治疗后最长15年内至少每年尝试联系受治者，了解是否发生不良反应。本研究不提供治疗，仅对既往参加美国国家癌症研究所（NCI）外科分部基因治疗试验、且已退出原试验的患者进行随访。 目的：收集既往参加基因转移研究者的长期随访数据，以满足监管要求。 资格：年龄≥18岁，既往参加过NCI外科分部的基因治疗研究。 研究流程：参加者接受基因修饰细胞后，于第3、6、12个月采血；随后4年每年到诊所访视并接受体格检查，回答神经系统、自身免疫性或血液系统疾病、新发癌症等相关问题，必要时采血；再之后10年每年通过电话或电子邮件联系并询问健康状况，也可能采血。研究人员还会询问当前住址和电话号码，并请参加者提供1至2名了解其去向者（尽可能包括一名家庭成员）的联系方式。若参加者死亡，研究人员将向家属征求尸检许可。
Background: \- Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial. Objective: \- To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators. Eligibility: \- People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study. Design: * After they get the genetically modified cells, participants will: * Have blood drawn 3, 6, and 12 months later. * Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn. * Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken. * Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible, * At the time of the participant s death, researchers will request permission from their family for an autopsy.
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