NCT05978141招募中不适用
The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 50
- 主要终点
- Number of participants populating the T-cell Lymphoma Master Repository/TCLMR
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Participants with T-Cell Lymphoma
Participants with pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma
干预措施: Optional Blood Sample and Nail Sample (Other)
结局指标
主要结局
Number of participants populating the T-cell Lymphoma Master Repository/TCLMR
时间窗: 10 years
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.
次要结局
未报告次要终点
研究者
研究点 (50)
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