Multicenter National ITP Registry and Accompanying Biospecimen Collection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 64
- 主要终点
- epidemiological data on ITP - Incidence
研究概览
简要总结
The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.
详细描述
Immune thrombocytopenia (ITP) is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets.
In recent years, new treatment options for patients with immune thrombocytopenia have emerged.
The results of published clinical studies on ITP can only be used for broad patient care to a limited extent, as they are designed for a patient population with clearly defined inclusion and exclusion criteria. Real world data collected from this registry will help to better understand the diagnosis and therapy of ITP patients in everyday treatment and to more effectively direct individual patients to optimal therapy, thus improving their outcomes.
By collecting biospecimens, this project will contribute new knowledge to the study of ITP through standardized, systematic, and high-quality collection and storage of patient samples and associated data.
The registry collects clinical data from patients diagnosed with ITP at defined points in the course of the disease. The Data collection includes a range of clinical measures, disease-related factors, treatment/treatment course and outcomes, complications during treatment and Qol, fatigue scoring and survival data (up to 5 years).
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
- •Primary or secondary Immune Thrombocytopenia (ITP)
- •Age ≥18 years
- •signed declaration of consent
排除标准
- •diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
- •no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)
结局指标
主要结局
epidemiological data on ITP - Incidence
时间窗: At enrollment
Incidence: number of reported ITP, estimate incidence by zip code area
ITP treatment type received
时间窗: 5 years
Medical therapies received
Remission
时间窗: 5 years
Remission Status
epidemiological data on ITP - Age
时间窗: At enrollment
Age (year of birth)
Description of the causes of ITP
时间窗: At enrollment
causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)
epidemiological data on ITP - Sex distribution
时间窗: At enrollment
Sex distribution: female, male
次要结局
- Laboratory parameters ANA(At enrollment, 6 months, annually up to 5 years)
- Recording of clinical characteristics of affected patients- platelet counts(At enrollment, 6 months, annually up to 5 years)
- thromboembolic events(At enrollment, 6 months, annually up to 5 years)
- Laboratory parameters APL-Antibodies(At enrollment, 6 months, annually up to 5 years)
- Recording of clinical characteristics of affected patients -disease manifestation at diagnosis(At enrollment)
- fatigue assessment(At enrollment, 6 months, annually up to 5 years)
- Laboratory parameters helicobacter pylori(At enrollment, 6 months, annually up to 5 years)
- Recording of clinical characteristics of affected patients - Disease stage(At enrollment, 6 months, annually up to 5 years)
- Bleeding events(At enrollment, 6 months, annually up to 5 years)
- Quality of Life questionaire(At enrollment, 6 months, annually up to 5 years)
- Laboratory parameters Lupus-Antibodies(At enrollment, 6 months, annually up to 5 years)
- Laboratory parameters platelet autoantibodies(At enrollment, 6 months, annually up to 5 years)
研究者
Thomas Stauch
Principal Investigator
Jena University Hospital