肿瘤细胞治疗研究
英文原题：A Registry for People With T-cell Lymphoma
A Registry for People With T-cell Lymphoma
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项观察性研究，观察细胞治疗用于淋巴瘤、白血病、外周 T 细胞淋巴瘤的真实世界诊疗与结局。当前状态：招募中。计划入组 1000 例。试验地点：美国 · 杜阿尔特、圣迭戈、旧金山、斯坦福（共 26 个中心）。登记号：NCT05978141。
不限性别
纳入标准： • 签署书面知情同意书； • 有合格的新鲜或存档肿瘤活检标本，或计划获取新鲜肿瘤活检标本； • 经病理学确诊为成熟T细胞或自然杀伤（NK）细胞淋巴瘤，符合以下诊断之一（依据WHO分类和NCCN指南）： • T细胞幼淋巴细胞白血病；T细胞大颗粒淋巴细胞白血病；NK细胞慢性淋巴增殖性疾病；侵袭性NK细胞白血病；儿童系统性EB病毒（EBV）阳性T细胞淋巴瘤；T/NK细胞型慢性活动性EBV感染（系统型）；水痘样淋巴细胞增殖性疾病；成人T细胞白血病/淋巴瘤；结外鼻型NK/T细胞淋巴瘤；肠病相关T细胞淋巴瘤；单形性嗜上皮性肠道T细胞淋巴瘤；肠道T细胞淋巴瘤（未另行分类，NOS）；胃肠道惰性T细胞淋巴增殖性疾病；肝脾T细胞淋巴瘤；皮下脂膜炎样T细胞淋巴瘤；蕈样肉芽肿（仅限≥IB期且正在接受积极治疗者）；Sézary综合征；原发性皮肤间变性大细胞淋巴瘤（接受全身治疗）；原发性皮肤γδT细胞淋巴瘤；原发性皮肤CD8+侵袭性亲表皮细胞毒性T细胞淋巴瘤；原发性皮肤肢端CD8+ T细胞淋巴瘤（接受全身治疗）；外周T细胞淋巴瘤（未另行分类）；血管免疫母细胞性T细胞淋巴瘤；滤泡性T细胞淋巴瘤；具有滤泡辅助性T细胞（TFH）表型的淋巴结型外周T细胞淋巴瘤；ALK阳性间变性大细胞淋巴瘤；ALK阴性间变性大细胞淋巴瘤；乳房植入物相关间变性大细胞淋巴瘤。 注：蕈样肉芽肿、原发性皮肤间变性大细胞淋巴瘤和/或原发性皮肤肢端CD8+ T细胞淋巴瘤患者必须接受全身治疗。 排除标准： • 蕈样肉芽肿、原发性皮肤间变性大细胞淋巴瘤和/或原发性皮肤肢端CD8+ T细胞淋巴瘤患者未接受全身治疗； • 根据主治医师临床判断，无法收集前瞻性数据、评估疗效或进行充分随访。 注：参加登记库不妨碍参加临床试验；已参加临床试验也不妨碍加入本研究。
Inclusion Criteria: * Written informed consent * Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy. * Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines): * T-cell prolymphocytic leukemia * T-cell large granular lymphocytic leukemia * Chronic lymphoproliferative disorder of NK cells * Aggressive NK-cell leukemia * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood * Chronic active EBV infection of T- and NK-cell type, systemic form * Hydroa vacciniforme-like lymphoproliferative disorder * Adult T-cell leukemia/lymphoma * Extranodal NK/T-cell lymphoma, nasal type * Enteropathy-associated T-cell lymphoma * Monomorphic epitheliotropic intestinal T-cell lymphoma * Intestinal T-cell lymphoma, not otherwise specified (NOS) * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract * Hepatosplenic T-cell lymphoma * Subcutaneous panniculitis-like T-cell lymphoma * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy) * Sézary syndrome * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy) * Primary cutaneous Gamma-Delta T-cell lymphoma * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy) * Peripheral T-cell lymphoma, not otherwise specified * Angioimmunoblastic T-cell lymphoma * Follicular T-cell lymphoma * Nodal peripheral T-cell lymphoma with TFH phenotype * Anaplastic large cell lymphoma, ALK-positive * Anaplastic large cell lymphoma, ALK-negative * Breast-implant associated anaplastic large cell lymphoma. * NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy. Exclusion Criteria: * Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and/or primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy. * Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.
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：Number of participants populating the T-cell Lymphoma Master Repository/TCLMR · To develop and populate a secure database comprised of patients with T-cell lymphomas with curated clinical characteristics and treatment outcomes matched to pathological biospecimens. · 10 years
经病理学确诊为成熟T细胞或自然杀伤（NK）细胞淋巴瘤的参与者。
以上邮箱 / 电话是登记库里的申办方联系方式，通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
本登记研究旨在建立信息数据库，以更好地了解T细胞淋巴瘤。研究人员将利用数据库信息，探索如何改善T细胞淋巴瘤患者的结局。
The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.
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