ITP-Registry: ITP Registry and Accompanying Biospecimen Collection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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).
The data are collected prospectively. In addition, patients can be included retrospectively up to 12 months after the initial diagnosis if continuous documentation can be provided at the treatment centre. In both cases, a written declaration of consent is obligatory.
Study Design
Outcome Measures
Primary Outcome Measures
- epidemiological data on ITP - Incidence [At enrollment]
Incidence: number of reported ITP, estimate incidence by zip code area
- epidemiological data on ITP - Age [At enrollment]
Age (year of birth)
- epidemiological data on ITP - Sex distribution [At enrollment]
Sex distribution: female, male
- Description of the causes of ITP [At enrollment]
causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)
- ITP treatment type received [5 years]
Medical therapies received
- Remission [5 years]
Remission Status
Secondary Outcome Measures
- Recording of clinical characteristics of affected patients - Disease stage [At enrollment, 6 months, annually up to 5 years]
bleeding severity WHO-CTCAE Grade 1-4
- Recording of clinical characteristics of affected patients- platelet counts [At enrollment, 6 months, annually up to 5 years]
platelet counts in Gpt/l
- Recording of clinical characteristics of affected patients -disease manifestation at diagnosis [At enrollment]
Localisation of bleeding and severity (WHO-CTCAE Grading)
- Bleeding events [At enrollment, 6 months, annually up to 5 years]
Bleeding events (yes, no)
- thromboembolic events [At enrollment, 6 months, annually up to 5 years]
thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other)
- Quality of Life questionaire [At enrollment, 6 months, annually up to 5 years]
ILQI questionaire
- fatigue assessment [At enrollment, 6 months, annually up to 5 years]
FACIT-F questionaire: subscale fatigue (only last 13 questions)
- Laboratory parameters ANA [At enrollment, 6 months, annually up to 5 years]
ANA (negative/positive)
- Laboratory parameters APL-Antibodies [At enrollment, 6 months, annually up to 5 years]
APL-Antibodies (negative/positive)
- Laboratory parameters Lupus-Antibodies [At enrollment, 6 months, annually up to 5 years]
lupus-Antibodies (negative/positive)
- Laboratory parameters platelet autoantibodies [At enrollment, 6 months, annually up to 5 years]
platelet autoantibodies (negative/positive)
- Laboratory parameters helicobacter pylori [At enrollment, 6 months, annually up to 5 years]
helicobacter pylori (negative/positive)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary or secondary Immune Thrombocytopenia (ITP)
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Age ≥18 years
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signed declaration of consent
Exclusion Criteria:
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diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
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no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Jena | Jena | Germany | 07745 |
Sponsors and Collaborators
- Jena University Hospital
- University Hospital Dresden
- Novartis
- Swedish Orphan Biovitrum
- Grifols Biologicals, LLC
- Amgen
- argenx
Investigators
- Study Director: Thomas Stauch, Dr. med., Jena University Hospital
- Study Director: Karolin Trautmann-Grill, Dr. med., Dresden Univeristy Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZKSJ0142