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| Name | Class |
|---|---|
| University Hospital Dresden | OTHER |
| Novartis | INDUSTRY |
| Swedish Orphan Biovitrum | INDUSTRY |
| Grifols Biologicals, LLC |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| epidemiological data on ITP - Incidence | Incidence: number of reported ITP, estimate incidence by zip code area | At enrollment |
| epidemiological data on ITP - Age | Age (year of birth) | At enrollment |
| epidemiological data on ITP - Sex distribution | Sex distribution: female, male | At enrollment |
| Description of the causes of ITP | causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others) | At enrollment |
| ITP treatment type received | Medical therapies received | 5 years |
| Remission | Remission Status | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of clinical characteristics of affected patients - Disease stage | bleeding severity WHO-CTCAE Grade 1-4 | At enrollment, 6 months, annually up to 5 years |
| Recording of clinical characteristics of affected patients- platelet counts |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Immune thrombocytopenia (ITP) which 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. There is a distinction between a primary form, in which no triggering cause is identifiable, and secondary forms, which may for example occur in the context of systemic autoimmune diseases or drug-induced.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Stauch, Dr. med. | Contact | 0049-3641-9326864 | thomas.stauch@med.uni-jena.de | |
| Karolin Trautmann-Grill, Dr. med. | Contact | 0049-351-45818229 | Karolin.Trautmann@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Stauch, Dr. med. | Jena University Hospital | Study Director |
| Karolin Trautmann-Grill, Dr. med. | Dresden Univeristy Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen AöR | Recruiting | Aachen | 52074 | Germany |
There is no validated data sharing procedure at the university hospital Jena. But of course it is planned to share the results with scientific community and publish the data in a scientific journal.
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| INDUSTRY |
| Amgen | INDUSTRY |
| argenx | INDUSTRY |
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18 mL whole blood (peripheral venipuncture) and 9 ml bone marrow
platelet counts in Gpt/l
| At enrollment, 6 months, annually up to 5 years |
| Recording of clinical characteristics of affected patients -disease manifestation at diagnosis | Localisation of bleeding and severity (WHO-CTCAE Grading) | At enrollment |
| Bleeding events | Bleeding events (yes, no) | At enrollment, 6 months, annually up to 5 years |
| thromboembolic events | thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other) | At enrollment, 6 months, annually up to 5 years |
| Quality of Life questionaire | ILQI questionaire | At enrollment, 6 months, annually up to 5 years |
| fatigue assessment | FACIT-F questionaire: subscale fatigue (only last 13 questions) | At enrollment, 6 months, annually up to 5 years |
| Laboratory parameters ANA | ANA (negative/positive) | At enrollment, 6 months, annually up to 5 years |
| Laboratory parameters APL-Antibodies | APL-Antibodies (negative/positive) | At enrollment, 6 months, annually up to 5 years |
| Laboratory parameters Lupus-Antibodies | lupus-Antibodies (negative/positive) | At enrollment, 6 months, annually up to 5 years |
| Laboratory parameters platelet autoantibodies | platelet autoantibodies (negative/positive) | At enrollment, 6 months, annually up to 5 years |
| Laboratory parameters helicobacter pylori | helicobacter pylori (negative/positive) | At enrollment, 6 months, annually up to 5 years |
| Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie | Recruiting | Altenburg | 04600 | Germany |
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| MVZ am Klinikum Aschaffenburg | Recruiting | Aschaffenburg | 63739 | Germany |
|
| MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus | Recruiting | Bad Homburg | 61352 | Germany |
|
| Onkologie/Hämatologie | Recruiting | Bad Liebenwerda | 04924 | Germany |
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| Charité Universitätsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
|
| Praxis für Hämatologie und Onkologie Berlin-Mitte | Recruiting | Berlin | 10117 | Germany |
|
| Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain | Recruiting | Berlin | 10249 | Germany |
|
| Onkologie am Segelfliegerdamm | Recruiting | Berlin | 12487 | Germany |
|
| MVZ Hämatologikum GmbH | Recruiting | Biberach | 88400 | Germany |
|
| Augusta-Kranken-Anstalt gGmbH | Recruiting | Bochum | 44791 | Germany |
|
| Klinikum Chemnitz gGmbH | Recruiting | Chemnitz | 09116 | Germany |
|
| MVZ Klinikum Coburg GmbH | Recruiting | Coburg | 96450 | Germany |
|
| Klinikum Darmstadt | Not yet recruiting | Darmstadt | 64283 | Germany |
| ARGE e.V. | Recruiting | Donauwörth | 86609 | Germany |
|
| Onkozentrum Dresden/Freiberg | Recruiting | Dresden | 01127 | Germany |
|
| Gemeinschaftspraxis Hämatologie-Onkologie | Recruiting | Dresden | 01307 | Germany |
|
| Gemeinschaftspraxis Mohm & Prange-Krex | Recruiting | Dresden | 01307 | Germany |
|
| Universitätsklinikum Dresden | Recruiting | Dresden | 01307 | Germany |
|
| Krankenhaus Düren gGmbH | Recruiting | Düren | 52351 | Germany |
|
| Onkologische Praxis Erfurt | Recruiting | Erfurt | 99084 | Germany |
|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
|
| MVZ für Hämatologie und Onkologie Essen | Recruiting | Essen | 45136 | Germany |
|
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt am Main | 60590 | Germany |
|
| Haemostas-Frankfurt | Recruiting | Frankfurt am Main | 60596 | Germany |
|
| PIOH Studien und Management GbR | Recruiting | Frechen | 50226 | Germany |
|
| Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei | Recruiting | Garbsen | 30823 | Germany |
|
| IOGP Gera MVZ GmbH | Recruiting | Gera | 07548 | Germany |
|
| ALB FILS Kliniken, Klinik am Eichert | Recruiting | Göppingen | 73035 | Germany |
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| Universitätsklinik Greifswald | Recruiting | Greifswald | 17475 | Germany |
|
| Katholisches Krankenhaus Hagen gGmbH | Recruiting | Hagen | 58097 | Germany |
|
| Gemeinschaftspraxis, FA für Innere Medizin | Recruiting | Halle | 06110 | Germany |
|
| MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH | Recruiting | Halle | 06110 | Germany |
|
| Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH | Recruiting | Hamburg | 22767 | Germany |
|
| Werlhof-Institut MVZ GmbH | Recruiting | Hanover | 30159 | Germany |
|
| Onkologie am Raschplatz | Recruiting | Hanover | 30161 | Germany |
|
| Dres. Kamal & Dorn GbR | Recruiting | Hanover | 30625 | Germany |
|
| ODZ-Petersen GmbH | Recruiting | Heidenheim | 89522 | Germany |
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| St. Bernward Krankenhaus GmbH | Recruiting | Hildesheim | 31134 | Germany |
|
| Klinikum Idar-Oberstein GmbH | Recruiting | Idar-Oberstein | 55743 | Germany |
|
| University Hospital Jena | Recruiting | Jena | 07745 | Germany |
|
| Klinikum Kassel GmbH | Recruiting | Kassel | 34125 | Germany |
|
| Universitätsklinikum Schleswig-Holstein | Recruiting | Kiel | 24105 | Germany |
|
| Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin | Recruiting | Koblenz | 56073 | Germany |
|
| Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung | Recruiting | Kronach | 96317 | Germany |
|
| MVZ mbH, Onkologische Schwerpunktpraxis | Recruiting | Leer | 26789 | Germany |
|
| Universitätsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
|
| OnkoFor Leipzig GmbH | Recruiting | Leipzig | 04289 | Germany |
|
| Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie | Recruiting | Magdeburg | 39120 | Germany |
|
| Carl-von-Basedow Klinikum Merseburg | Recruiting | Merseburg | 06217 | Germany |
|
| Gemeinschaftspraxis Hämato-Onkologie | Recruiting | München | 81241 | Germany |
|
| Dietrich-Bonhoeffer-Klinikum Neubrandenburg | Recruiting | Neubrandenburg | 17036 | Germany |
|
| MVZ Onko Medical GmbH Neustadt | Recruiting | Neustadt am Rübenberge | 31535 | Germany |
|
| Pi.Tri.-Studien GmbH | Recruiting | Offenburg | 77654 | Germany |
|
| Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa | Recruiting | Riesa | 01589 | Germany |
|
| Klinikum Südstadt Rostock | Recruiting | Rostock | 18059 | Germany |
|
| Medcenter Nordsachsen | Recruiting | Schkeuditz | 04435 | Germany |
|
| MVZ am Schlossgarten, Zero Praxen | Recruiting | Schwetzingen | 68723 | Germany |
|
| Onkologiezentrum Soest/Iserlohn | Recruiting | Soest | 59494 | Germany |
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| Bundeswehrkrankenhaus Ulm | Recruiting | Ulm | 89081 | Germany |
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| Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH | Recruiting | Villingen-Schwenningen | 78052 | Germany |
|
| Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH | Recruiting | Wolfsburg | 38440 | Germany |
|
| Universitätsklinikum Würzburg | Recruiting | Würzburg | 97080 | Germany |
|
| Praxis für Hämatologie und Internistische Onkologie | Recruiting | Zittau | 02763 | Germany |
|
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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