Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 5
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.
详细描述
Primary cutaneous lymphomas (PCLs) are defined as non-Hodgkin lymphomas presenting in the skin with no evidence of extracutaneous disease at the time of diagnosis. Primary cutaneous lymphomas include a heterogeneous group of cutaneous T-cell lymphomas (CTCLs) and cutaneous B-cell lymphomas (CBCLs). The different types of PCLs have highly characteristic clinical and histologic features, often a completely different clinical behavior and prognosis, and require a different type of treatment. Various studied in terms of the treatment and outcome of patients with different types of PCLs has been conducted in recent years. While the data of Chinese patients with PCLs are limited. Considering the different proportion of PCLs and limited treatment modalities in China, a nationwide multi-center prospective study is designed to summarize the current treatment status and outcome of patients.
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
- •Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
- •Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.
排除标准
- •Patients who fail to provide informed consent form.
- •Patients who cannot complete the questionnaire independently or under the guidance of investigators.
结局指标
主要结局
Objective response rate(ORR)
时间窗: Through study completion, an average of 1 year.
Proportion of patients with CR and PR.
Time-to-next treatment (TTNT)
时间窗: At the time of treatment change, through study completion, an average of 3 months.
Date of initiation of primary treatment to date of new significant treatment.
Type of significant therapies
时间窗: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy.
Time to response (TTR)
时间窗: At the time of response, through study completion, an average of 3 months.
Date of initiation of treatment to date when criteria for response (PR or CR) first met.
Time to treatment failure (TTF)
时间窗: At the time of treatment failure, through study completion, an average of 3 months.
Date of initiation of treatment until abandonment of therapy, causes of abandonment of therapy may include inadequate response to therapy, intolerable side effects or toxicity, disease progression, and patient withdrawal for whatever reason.
Duration of significant therapies
时间窗: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month".
Clinical response to significant therapies
时间窗: At the each scheduled follow-up visit through study completion, an average of 3 months
Clinical response are assessed by consensus response criteria in PCLs (Olsen, Elise A et al. "Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC." Blood vol. 140,5 (2022): 419-437. ), recorded as "CR", "PR", "SD" or "PD".
次要结局
- Disease Specific Survival (DSS)(Baseline and the time of death due to disease, through study completion, an average of 1 year.)
- Overall survival (OS)(Baseline and at time of occurrence of death, through study completion, an average of 1 year.)
- Progression Free Survival (PFS)(Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.)
- Disease Free Survival (DFS)(Date when criteria for CR first met and date when criteria for relapse/recurrence or or death from any cause, through study completion, an average of 1 year.)
研究者
Yang WANG
Department of Dermatology and Venereology
Peking University First Hospital