ITP Registry and Accompanying Biospecimen Collection

NCT ID: NCT05152238

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Immune Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dresden

OTHER

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role collaborator

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

argenx

INDUSTRY

Sponsor Role collaborator

Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thomas Stauch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Stauch, Dr. med.

Role: STUDY_DIRECTOR

Jena University Hospital

Karolin Trautmann-Grill, Dr. med.

Role: STUDY_DIRECTOR

Dresden Univeristy Hospital

Locations

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Universitätsklinikum Aachen AöR

Aachen, , Germany

Site Status RECRUITING

Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie

Altenburg, , Germany

Site Status RECRUITING

MVZ am Klinikum Aschaffenburg

Aschaffenburg, , Germany

Site Status RECRUITING

MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus

Bad Homburg, , Germany

Site Status RECRUITING

Onkologie/Hämatologie

Bad Liebenwerda, , Germany

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Praxis für Hämatologie und Onkologie Berlin-Mitte

Berlin, , Germany

Site Status RECRUITING

Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain

Berlin, , Germany

Site Status RECRUITING

Onkologie am Segelfliegerdamm

Berlin, , Germany

Site Status RECRUITING

MVZ Hämatologikum GmbH

Biberach, , Germany

Site Status RECRUITING

Augusta-Kranken-Anstalt gGmbH

Bochum, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

MVZ Klinikum Coburg GmbH

Coburg, , Germany

Site Status RECRUITING

Klinikum Darmstadt

Darmstadt, , Germany

Site Status NOT_YET_RECRUITING

ARGE e.V.

Donauwörth, , Germany

Site Status RECRUITING

Onkozentrum Dresden/Freiberg

Dresden, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Mohm & Prange-Krex

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Dresden

Dresden, , Germany

Site Status RECRUITING

Krankenhaus Düren gGmbH

Düren, , Germany

Site Status RECRUITING

Onkologische Praxis Erfurt

Erfurt, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

MVZ für Hämatologie und Onkologie Essen

Essen, , Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt

Frankfurt am Main, , Germany

Site Status RECRUITING

Haemostas-Frankfurt

Frankfurt am Main, , Germany

Site Status RECRUITING

PIOH Studien und Management GbR

Frechen, , Germany

Site Status RECRUITING

Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei

Garbsen, , Germany

Site Status RECRUITING

IOGP Gera MVZ GmbH

Gera, , Germany

Site Status RECRUITING

ALB FILS Kliniken, Klinik am Eichert

Göppingen, , Germany

Site Status RECRUITING

Universitätsklinik Greifswald

Greifswald, , Germany

Site Status RECRUITING

Katholisches Krankenhaus Hagen gGmbH

Hagen, , Germany

Site Status RECRUITING

Gemeinschaftspraxis, FA für Innere Medizin

Halle, , Germany

Site Status RECRUITING

MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH

Halle, , Germany

Site Status RECRUITING

Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH

Hamburg, , Germany

Site Status RECRUITING

Werlhof-Institut MVZ GmbH

Hanover, , Germany

Site Status RECRUITING

Onkologie am Raschplatz

Hanover, , Germany

Site Status RECRUITING

Dres. Kamal & Dorn GbR

Hanover, , Germany

Site Status RECRUITING

ODZ-Petersen GmbH

Heidenheim, , Germany

Site Status RECRUITING

St. Bernward Krankenhaus GmbH

Hildesheim, , Germany

Site Status RECRUITING

Klinikum Idar-Oberstein GmbH

Idar-Oberstein, , Germany

Site Status RECRUITING

University Hospital Jena

Jena, , Germany

Site Status RECRUITING

Klinikum Kassel GmbH

Kassel, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status RECRUITING

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin

Koblenz, , Germany

Site Status RECRUITING

Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung

Kronach, , Germany

Site Status RECRUITING

MVZ mbH, Onkologische Schwerpunktpraxis

Leer, , Germany

Site Status RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status RECRUITING

OnkoFor Leipzig GmbH

Leipzig, , Germany

Site Status RECRUITING

Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie

Magdeburg, , Germany

Site Status RECRUITING

Carl-von-Basedow Klinikum Merseburg

Merseburg, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Hämato-Onkologie

München, , Germany

Site Status RECRUITING

Dietrich-Bonhoeffer-Klinikum Neubrandenburg

Neubrandenburg, , Germany

Site Status RECRUITING

MVZ Onko Medical GmbH Neustadt

Neustadt am Rübenberge, , Germany

Site Status RECRUITING

Pi.Tri.-Studien GmbH

Offenburg, , Germany

Site Status RECRUITING

Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa

Riesa, , Germany

Site Status RECRUITING

Klinikum Südstadt Rostock

Rostock, , Germany

Site Status RECRUITING

Medcenter Nordsachsen

Schkeuditz, , Germany

Site Status RECRUITING

MVZ am Schlossgarten, Zero Praxen

Schwetzingen, , Germany

Site Status RECRUITING

Onkologiezentrum Soest/Iserlohn

Soest, , Germany

Site Status RECRUITING

Bundeswehrkrankenhaus Ulm

Ulm, , Germany

Site Status RECRUITING

Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, , Germany

Site Status RECRUITING

Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH

Wolfsburg, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Praxis für Hämatologie und Internistische Onkologie

Zittau, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Stauch, Dr. med.

Role: CONTACT

0049-3641-9326864

Karolin Trautmann-Grill, Dr. med.

Role: CONTACT

0049-351-45818229

Facility Contacts

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Gerda Silling, Dr

Role: primary

Christina Klötzer, Dr.

Role: primary

Manfred Welslau, Dr.

Role: primary

Rosa Sonja Alesci, Dr

Role: primary

Stephan Kreher, PD Dr.

Role: primary

Marie Luise Hütter-Krönke, Dr.

Role: primary

Stephan Fuhrmann, Dr.

Role: primary

Robert Klamroth, PD Dr.

Role: primary

Jörg Heßling, Dr.

Role: primary

Leonid Basovski, Dr.

Role: primary

Robert Radkowski, Dr.

Role: primary

Mathias Hänel, PD Dr.

Role: primary

Christof Lamberti, PD Dr.

Role: primary

Bastian Fleischmann

Role: primary

Steffen Dörfel

Role: primary

Thomas Illmer, PD Dr.

Role: primary

Johannes Mohm, Dr.

Role: primary

Karolin Trautmann-Grill, Dr.

Role: primary

Michael Flaßhove, PD Dr.

Role: primary

Ulrich Hauch, Dr.

Role: primary

Valeska Brückl, Dr.

Role: primary

Patricia Johansson, PD Dr.

Role: primary

Jörg Chromik, Dr.

Role: primary

Wolfgang Mondorf, Dr.

Role: primary

Marcel Reiser, PD Dr.

Role: primary

Petros Panagiotou

Role: primary

Steffen Gerhardt, Dr.

Role: primary

Johannes Niebling, Dr.

Role: primary

Thomas Neumann, Dr.

Role: primary

Doris Kraemer, Prof. Dr.

Role: primary

Regina Moeller, Dr.

Role: primary

Timo Behlendorf, Dr.

Role: primary

Julia Wiederhold

Role: primary

Kai Gutensohn, Prof. Dr.

Role: primary

Eyck von der Heyde, Dr.

Role: primary

Haytham Kamal, Dr.

Role: primary

Volker Petersen, Dr.

Role: primary

Ulrich Kaiser, Prof. Dr.

Role: primary

Marina Bischoff, Dr.

Role: primary

Thomas Stauch, MD

Role: primary

Martin Wolf, Prof. Dr.

Role: primary

Matthias Ritgen, Dr.

Role: primary

Jens-Marcus Chemnitz, Dr.

Role: primary

Martina Stauch, Dr.

Role: primary

Lothar Müller, Dr.

Role: primary

Carmen Herling, Dr.

Role: primary

Andreas Schwarzer, Dr.

Role: primary

Tobias Ronny Haage, Dr.

Role: primary

Susann Schulze, Dr.

Role: primary

Matthias Zingerle, Dr.

Role: primary

Philipp Hemmati, PD Dr.

Role: primary

Munir Rababah, Dr.

Role: primary

Henning Pelz, Dr.

Role: primary

Jörg Schubert, Prof. Dr.

Role: primary

Beate Krammer-Steiner, Dr.

Role: primary

Leanthe Braunert, Dr.

Role: primary

Christian Kuhn, Dr.

Role: primary

Anke Wortmann, Dr.

Role: primary

Matthias Müller, Dr.

Role: primary

Paul La Rosée, Prof. Dr.

Role: primary

Thomas Gabrysiak, Dr.

Role: primary

Thomas Bumm, Dr.

Role: primary

Mathias Schulze, Dr.

Role: primary

Other Identifiers

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ZKSJ0142

Identifier Type: -

Identifier Source: org_study_id

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