A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas in the Spanish Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 主要终点
- Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
研究概览
简要总结
The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.
详细描述
This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).
This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/
- •Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
- •PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:
- •Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
- •Enteropathic T-cell lymphoma
- •Hepatosplenic T-cell lymphoma
- •Peripheral T-cell lymphoma, not otherwise specified
- •Angioimmunoblastic T-cell lymphoma
- •Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
- •Anaplastic large cell lymphoma, ALK-
排除标准
- •Participants with an unavailable history (lost, empty or not recoverable).
结局指标
主要结局
Distribution of Peripheral T-cell Lymphoma (PTCL) Subtypes
时间窗: Up to 6 months
Distribution of PTCL subtypes by re-analysis and re-classification of samples according to the 2008 WHO classification of lymphoid neoplasms will be estimated.
次要结局
- Percentage of Participants with Each Subtypes of PTCL(Up to 6 months)
- Expression of Cluster of Differentiation 30 (CD30) by Immunohistochemistry and Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in Different Subtypes of PTCL(Up to 6 months)
- Classification of Peripheral T-cell Lymphoma(Up to 6 months)
- T-cell Clonality in PTCL(Up to 6 months)
- Rate of Discrepancy Between the Initial Diagnosis and Re-analysis and Re-classification(Up to 6 months)
- Correlation Between the Expression of CD30 and Lymphoid Lineage(Up to 6 months)
- Correlation Between Most frequent Mutations and Clinical, Phenotypic Factors(Up to 6 months)
- Correlation Between the Expression of CD30, Prognostic Indices Used In PTCL and Survival(Up to 6 months)