Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 2,950
- 试验地点
- 1
- 主要终点
- Course of treatment (treatment reality)
研究概览
简要总结
The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.
详细描述
RUBIN is a national, observational, prospective, longitudinal, multicenter registry platform with the purpose to record information on the antineoplastic treatment of hematological malignancies in Germany.
It will identify common therapeutic sequences and changes in the treatment of the disease, and will analyse the impact of novel treatments on the outcome of patients in routine care. Unmet needs and areas with the potential for improvement in routine care are to be identified.
At inclusion, data in patient characteristics, comorbidities, clinical characteristics and previous treatments, if applicable, are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and clinical outcome are documented.
Health-realted quality of life in patients with hematological malignancies will be evaluated for up to one year.
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
- •Confirmed diagnosis of the respective NHL
- •If patient is alive: signed written informed consent
- •For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.
- •For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.
排除标准
- •No systemic therapy for respective lymphoid malignancy.
研究组 & 干预措施
Waldenström's macroglobulinemia (WM)
Patients with WM receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
Mantle Cell Lymphoma (MCL)
Patients with MCL receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
Chronic Lymphocytic Leukemia (CLL)
Patients with CLL receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
Diffuse Large B-cell Lymphoma (DLBCL)
Patients with DLBCL receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
Follicular Lymphoma (FL)
Patients with FL receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
Marginal Zone Lymphoma (MZL)
Patients with MZL receiving systemic treatment (physician's choice)
干预措施: Routine care as per site standard. (Other)
结局指标
主要结局
Course of treatment (treatment reality)
时间窗: 5 years
Documentation of anamnestic data and therapy sequences. Documentation of anamnestic data and therapy sequences
次要结局
- Overall survival(5 years)
- Best Response(5 years)
- Disease-specific quality of life (Patient-reported outcome, patients with CLL)(1 year)
- Disease-specific quality of life (Patient-reported outcome, patients with LG-NHL)(1 year)
- Disease-specific quality of life (Patient-reported outcome, patients with HG-NHL)(1 year)
- Progression-free survival(5 years)
- Health-related quality of life (Patient-reported outcome)(1 year)