A Multicenter, Non-interventional, Two-cohort Study to Describe Real-world Treatment Patterns and Outcomes in Patients With Peripheral T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Distribution of PTCL Histological Subtypes according to WHO 2016 Classification
研究概览
简要总结
This study aims to characterize the epidemiology, clinicopathologic features, and survival outcomes of Chinese patients with PTCL; to develop and validate prognostic models to this population; to compare the real-world effectiveness and safety of alternative therapeutic strategies; to elucidate molecular mechanisms underlying treatment resistance and relapse; to identify actionable targets and predictive biomarkers.
详细描述
Due to disease heterogeneity and variability in clinical practice, establishing a large-scale Chinese PTCL database to characterize real-world treatment patterns and clinical outcomes is a critical undertaking. A retrospective cohort will define the clinical epidemiology of the disease, while a prospective cohort will delineate current treatment pathways and outcomes in routine practice and explore the molecular features of PTCL in the Chinese population, thereby providing evidence to support precision therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, with a histopathologic diagnosis of PTCL (any subtype per WHO 2016 classification of hematolymphoid neoplasms).
- •Cohort A: Patients diagnosed and treated at participating centers between 2010 and
- •Cohort B: Patients newly diagnosed from October 2025 onward.
- •Availability of basic diagnostic and treatment records .
排除标准
- •Indeterminate diagnosis or missing pathology report.
- •Patients diagnosed at an outside institution who did not receive their primary treatment and follow-up at a participating center.
- •Diagnoses of NK/T-cell lymphoma or primary cutaneous T-cell lymphomas.
结局指标
主要结局
Distribution of PTCL Histological Subtypes according to WHO 2016 Classification
时间窗: Baseline (at the time of enrollment or diagnosis)
The number and percentage of participants diagnosed with each specific subtype of Peripheral T-Cell Lymphoma (e.g., PTCL-NOS, AITL, ALCL, ENKTL, etc.). Diagnosis is confirmed by pathological review based on the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition, 2017).
Progression-Free Survival (PFS)
时间窗: 5 year after diagnosis
PFS is defined as the time from the date of pathological diagnosis to the date of the first documented disease progression (PD) or death from any cause, whichever occurs first. Disease progression is assessed based on the investigator's evaluation of radiological and clinical data.
Overall Survival (OS)
时间窗: 5 year after diagnosis
OS is defined as the time from the date of pathological diagnosis to the date of death from any cause. For patients who are lost to follow-up, survival time will be censored at the date of last contact.
次要结局
- Expression levels of biomarker proteins(Up to 5 years (at Baseline and at time of Disease Progression/Relapse))
- Frequency of Specific Genetic Mutations(Up to 5 years (at Baseline and at time of Disease Progression/Relapse))
- Incidence of Treatment-Emergent Adverse Events (TEAEs) assessed by CTCAE v5.0(Up to 5 years)
研究者
Rong Tao
Professor & Chief
Fudan University