ITP Registry and Accompanying Biospecimen Collection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immune Thrombocytopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter National ITP Registry and Accompanying Biospecimen Collection
Overview
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.
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.
Primary outcome measures
- epidemiological data on ITP - Incidence [Time frame: At enrollment]
- epidemiological data on ITP - Age [Time frame: At enrollment]
- epidemiological data on ITP - Sex distribution [Time frame: At enrollment]
- Description of the causes of ITP [Time frame: At enrollment]
- ITP treatment type received [Time frame: 5 years]
- Remission [Time frame: 5 years]
Secondary outcome measures (12)
- Recording of clinical characteristics of affected patients - Disease stage [Time frame: At enrollment, 6 months, annually up to 5 years]
- Recording of clinical characteristics of affected patients- platelet counts [Time frame: At enrollment, 6 months, annually up to 5 years]
- Recording of clinical characteristics of affected patients -disease manifestation at diagnosis [Time frame: At enrollment]
- Bleeding events [Time frame: At enrollment, 6 months, annually up to 5 years]
- thromboembolic events [Time frame: At enrollment, 6 months, annually up to 5 years]
- Quality of Life questionaire [Time frame: At enrollment, 6 months, annually up to 5 years]
- fatigue assessment [Time frame: At enrollment, 6 months, annually up to 5 years]
- Laboratory parameters ANA [Time frame: At enrollment, 6 months, annually up to 5 years]
- Laboratory parameters APL-Antibodies [Time frame: At enrollment, 6 months, annually up to 5 years]
- Laboratory parameters Lupus-Antibodies [Time frame: At enrollment, 6 months, annually up to 5 years]
- Laboratory parameters platelet autoantibodies [Time frame: At enrollment, 6 months, annually up to 5 years]
- Laboratory parameters helicobacter pylori [Time frame: At enrollment, 6 months, annually up to 5 years]
Eligibility criteria
Inclusion criteria
- Primary or secondary Immune Thrombocytopenia (ITP)
- Age ≥18 years
- signed declaration of consent
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 64 centers
- Universitätsklinikum Aachen AöR — Aachen
- Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie — Altenburg
- MVZ am Klinikum Aschaffenburg — Aschaffenburg
- MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus — Bad Homburg
- Onkologie/Hämatologie — Bad Liebenwerda
- Charité Universitätsmedizin Berlin — Berlin
- Praxis für Hämatologie und Onkologie Berlin-Mitte — Berlin
- Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain — Berlin
- … and 56 more centers
Identifiers
NCT: NCT05152238 · ZKSJ0142