ITP Registry and Accompanying Biospecimen Collection
- Conditions
- Immune Thrombocytopenia
- Registration Number
- NCT05152238
- Lead Sponsor
- Jena University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- Primary or secondary Immune Thrombocytopenia (ITP)
- Age ≥18 years
- signed declaration of consent
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method epidemiological data on ITP - Incidence At enrollment Incidence: number of reported ITP, estimate incidence by zip code area
ITP treatment type received 5 years Medical therapies received
Remission 5 years Remission Status
epidemiological data on ITP - Age At enrollment Age (year of birth)
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)
epidemiological data on ITP - Sex distribution At enrollment Sex distribution: female, male
- Secondary Outcome Measures
Name Time Method Laboratory parameters ANA At enrollment, 6 months, annually up to 5 years ANA (negative/positive)
Recording of clinical characteristics of affected patients- platelet counts At enrollment, 6 months, annually up to 5 years platelet counts in Gpt/l
thromboembolic events At enrollment, 6 months, annually up to 5 years thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other)
Laboratory parameters APL-Antibodies At enrollment, 6 months, annually up to 5 years APL-Antibodies (negative/positive)
Recording of clinical characteristics of affected patients -disease manifestation at diagnosis At enrollment Localisation of bleeding and severity (WHO-CTCAE Grading)
fatigue assessment At enrollment, 6 months, annually up to 5 years FACIT-F questionaire: subscale fatigue (only last 13 questions)
Laboratory parameters helicobacter pylori At enrollment, 6 months, annually up to 5 years helicobacter pylori (negative/positive)
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
Bleeding events At enrollment, 6 months, annually up to 5 years Bleeding events (yes, no)
Quality of Life questionaire At enrollment, 6 months, annually up to 5 years ILQI questionaire
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)
Trial Locations
- Locations (62)
Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie
🇩🇪Magdeburg, Germany
Universitätsklinikum Aachen AöR
🇩🇪Aachen, Germany
Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie
🇩🇪Altenburg, Germany
MVZ am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus
🇩🇪Bad Homburg, Germany
Onkologie/Hämatologie
🇩🇪Bad Liebenwerda, Germany
Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain
🇩🇪Berlin, Germany
Onkologie am Segelfliegerdamm
🇩🇪Berlin, Germany
MVZ Hämatologikum GmbH
🇩🇪Biberach, Germany
Augusta-Kranken-Anstalt gGmbH
🇩🇪Bochum, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
MVZ Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
ARGE e.V.
🇩🇪Donauwörth, Germany
Onkozentrum Dresden/Freiberg
🇩🇪Dresden, Germany
Gemeinschaftspraxis Hämatologie-Onkologie
🇩🇪Dresden, Germany
Gemeinschaftspraxis Mohm & Prange-Krex
🇩🇪Dresden, Germany
Universitätsklinikum Dresden
🇩🇪Dresden, Germany
Krankenhaus Düren gGmbH
🇩🇪Düren, Germany
Onkologische Praxis Erfurt
🇩🇪Erfurt, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Haemostas-Frankfurt
🇩🇪Frankfurt am Main, Germany
PIOH Studien und Management GbR
🇩🇪Frechen, Germany
Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei
🇩🇪Garbsen, Germany
IOGP Gera MVZ GmbH
🇩🇪Gera, Germany
Universitätsklinik Greifswald
🇩🇪Greifswald, Germany
ALB FILS Kliniken, Klinik am Eichert
🇩🇪Göppingen, Germany
Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Gemeinschaftspraxis, FA für Innere Medizin
🇩🇪Halle, Germany
MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH
🇩🇪Halle, Germany
Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH
🇩🇪Hamburg, Germany
Werlhof-Institut MVZ GmbH
🇩🇪Hannover, Germany
Onkologie am Raschplatz
🇩🇪Hannover, Germany
Dres. Kamal & Dorn GbR
🇩🇪Hannover, Germany
ODZ-Petersen GmbH
🇩🇪Heidenheim, Germany
St. Bernward Krankenhaus GmbH
🇩🇪Hildesheim, Germany
Klinikum Idar-Oberstein GmbH
🇩🇪Idar-Oberstein, Germany
University Hospital Jena
🇩🇪Jena, Germany
Klinikum Kassel GmbH
🇩🇪Kassel, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
🇩🇪Koblenz, Germany
Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung
🇩🇪Kronach, Germany
MVZ mbH, Onkologische Schwerpunktpraxis
🇩🇪Leer, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
OnkoFor Leipzig GmbH
🇩🇪Leipzig, Germany
Carl-von-Basedow Klinikum Merseburg
🇩🇪Merseburg, Germany
Gemeinschaftspraxis Hämato-Onkologie
🇩🇪München, Germany
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
🇩🇪Neubrandenburg, Germany
MVZ Onko Medical GmbH Neustadt
🇩🇪Neustadt Am Rübenberge, Germany
Pi.Tri.-Studien GmbH
🇩🇪Offenburg, Germany
Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa
🇩🇪Riesa, Germany
Klinikum Südstadt Rostock
🇩🇪Rostock, Germany
Medcenter Nordsachsen
🇩🇪Schkeuditz, Germany
Asklepios Klinikum Uckermark
🇩🇪Schwedt/Oder, Germany
MVZ am Schlossgarten, Zero Praxen
🇩🇪Schwetzingen, Germany
Onkologiezentrum Soest/Iserlohn
🇩🇪Soest, Germany
Bundeswehrkrankenhaus Ulm
🇩🇪Ulm, Germany
Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH
🇩🇪Villingen-Schwenningen, Germany
Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH
🇩🇪Wolfsburg, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Praxis für Hämatologie und Internistische Onkologie
🇩🇪Zittau, Germany