ITP Registry and Accompanying Biospecimen Collection (ITP-Registry)

Multicenter National ITP Registry and Accompanying Biospecimen Collection

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Thrombocytopenia

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 Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Thomas Stauch, Dr. med.; Phone Number: 0049-3641-9326864; Email: thomas.stauch@med.uni-jena.de
• Study Contact Backup: Name: Karolin Trautmann-Grill, Dr. med.; Phone Number: 0049-351-45818229; Email: Karolin.Trautmann@uniklinikum-dresden.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Not yet recruiting
    • Universitätsklinikum Aachen AöR
    • Contact: Gerda Silling, Dr
  • Altenburg, Germany, 04600
    • Not yet recruiting
    • Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie
    • Contact: Romy Pomper, Dr.
  • Aschaffenburg, Germany, 63739
    • Recruiting
    • MVZ am Klinikum Aschaffenburg
    • Contact: Manfred Welslau, Dr.
  • Bad Homburg, Germany, 61352
    • Recruiting
    • MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus
    • Contact: Rosa Sonja Alesci, Dr
  • Bad Liebenwerda, Germany, 04924
    • Recruiting
    • Onkologie/Hämatologie
    • Contact: Stephan Kreher, PD Dr.
  • Berlin, Germany, 10249
    • Recruiting
    • Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain
    • Contact: Robert Klamroth, PD Dr.
  • Berlin, Germany, 12487
    • Recruiting
    • Onkologie am Segelfliegerdamm
    • Contact: Jörg Heßling, Dr.
  • Biberach, Germany, 88400
    • Recruiting
    • MVZ Hämatologikum GmbH
    • Contact: Leonid Basovski, Dr.
  • Bochum, Germany, 44791
    • Recruiting
    • Augusta-Kranken-Anstalt gGmbH
    • Contact: Robert Radkowski, Dr.
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
    • Contact: Mathias Hänel, PD Dr.
  • Coburg, Germany, 96450
    • Recruiting
    • MVZ Klinikum Coburg GmbH
    • Contact: Christof Lamberti, PD Dr.
  • Darmstadt, Germany, 64283
    • Recruiting
    • Klinikum Darmstadt
    • Contact: Jörg Herold, PD Dr.
  • Donauwörth, Germany, 86609
    • Recruiting
    • ARGE e.V.
    • Contact: Bastian Fleischmann
  • Dresden, Germany, 01307
    • Recruiting
    • Universitätsklinikum Dresden
    • Contact: Karolin Trautmann-Grill, Dr.
  • Dresden, Germany, 01127
    • Recruiting
    • Onkozentrum Dresden/Freiberg
    • Contact: Steffen Dörfel
  • Dresden, Germany, 01307
    • Recruiting
    • Gemeinschaftspraxis Hämatologie-Onkologie
    • Contact: Thomas Illmer, PD Dr.
  • Dresden, Germany, 01307
    • Recruiting
    • Gemeinschaftspraxis Mohm & Prange-Krex
    • Contact: Johannes Mohm, Dr.
  • Düren, Germany, 52351
    • Recruiting
    • Krankenhaus Düren gGmbH
    • Contact: Michael Flaßhove, PD Dr.
  • Erfurt, Germany, 99084
    • Recruiting
    • Onkologische Praxis Erfurt
    • Contact: Ulrich Hauch, Dr.
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitätsklinikum Erlangen
    • Contact: Valeska Brückl, Dr.
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Universitatsklinikum Frankfurt
    • Contact: Jörg Chromik, Dr.
  • Frankfurt am Main, Germany, 60596
    • Recruiting
    • Haemostas-Frankfurt
    • Contact: Wolfgang Mondorf, Dr.
  • Frechen, Germany, 50226
    • Recruiting
    • PIOH Studien und Management GbR
    • Contact: Marcel Reiser, PD Dr.
  • Garbsen, Germany, 30823
    • Recruiting
    • Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei
    • Contact: Petros Panagiotou
  • Gera, Germany, 07548
    • Recruiting
    • IOGP Gera MVZ GmbH
    • Contact: Steffen Gerhardt, Dr.
  • Greifswald, Germany, 17475
    • Recruiting
    • Universitatsklinik Greifswald
    • Contact: Thomas Neumann, Dr.
  • Göppingen, Germany, 73035
    • Recruiting
    • ALB FILS Kliniken, Klinik am Eichert
    • Contact: Johannes Niebling, Dr.
  • Hagen, Germany, 58097
    • Recruiting
    • Katholisches Krankenhaus Hagen gGmbH
    • Contact: Doris Kraemer, Prof. Dr.
  • Halle, Germany, 06110
    • Recruiting
    • Gemeinschaftspraxis, FA für Innere Medizin
    • Contact: Regina Moeller, Dr.
  • Halle, Germany, 06110
    • Recruiting
    • MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH
    • Contact: Timo Behlendorf, Dr.
  • Hamburg, Germany, 22767
    • Recruiting
    • Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH
    • Contact: Julia Wiederhold
  • Hannover, Germany, 30159
    • Recruiting
    • Werlhof-Institut MVZ GmbH
    • Contact: Kai Gutensohn, Prof. Dr.
  • Hannover, Germany, 30161
    • Recruiting
    • Onkologie am Raschplatz
    • Contact: Eyck von der Heyde, Dr.
  • Hannover, Germany, 30625
    • Recruiting
    • Dres. Kamal & Dorn GbR
    • Contact: Haytham Kamal, Dr.
  • Heidenheim, Germany, 89522
    • Recruiting
    • ODZ-Petersen GmbH
    • Contact: Volker Petersen, Dr.
  • Hildesheim, Germany, 31134
    • Recruiting
    • St. Bernward Krankenhaus GmbH
    • Contact: Ulrich Kaiser, Prof. Dr.
  • Idar-Oberstein, Germany, 55743
    • Recruiting
    • Klinikum Idar-Oberstein GmbH
    • Contact: Marina Bischoff, Dr.
  • Jena, Germany, 07745
    • Recruiting
    • University Hospital Jena
    • Contact: Thomas Stauch, MD
  • Kassel, Germany, 34125
    • Recruiting
    • Klinikum Kassel GmbH
    • Contact: Martin Wolf, Prof. Dr.
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein
    • Contact: Matthias Ritgen, Dr.
  • Koblenz, Germany, 56073
    • Recruiting
    • Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
    • Contact: Jens-Marcus Chemnitz, Dr.
  • Kronach, Germany, 96317
    • Recruiting
    • Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung
    • Contact: Martina Stauch, Dr.
  • Leer, Germany, 26789
    • Recruiting
    • MVZ mbH, Onkologische Schwerpunktpraxis
    • Contact: Lothar Müller, Dr.
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • Universitatsklinikum Leipzig
    • Contact: Carmen Herling, Dr.
  • Leipzig, Germany, 04289
    • Recruiting
    • OnkoFor Leipzig GmbH
    • Contact: Andreas Schwarzer, Dr.
  • Merseburg, Germany, 06217
    • Recruiting
    • Carl-von-Basedow Klinikum Merseburg
    • Contact: Susann Schulze, Dr.
  • München, Germany, 81241
    • Recruiting
    • Gemeinschaftspraxis Hämato-Onkologie
    • Contact: Matthias Zingerle, Dr.
  • Neubrandenburg, Germany, 17036
    • Not yet recruiting
    • Dietrich-Bonhoeffer-Klinikum Neubrandenburg
    • Contact: Philipp Hemmati, PD Dr.
  • Neustadt Am Rübenberge, Germany, 31535
    • Recruiting
    • MVZ Onko Medical GmbH Neustadt
    • Contact: Barbara Tschechne, Dr.
  • Offenburg, Germany, 77654
    • Recruiting
    • Pi.Tri.-Studien GmbH
    • Contact: Henning Pelz, Dr.
  • Riesa, Germany, 01589
    • Recruiting
    • Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa
    • Contact: Jörg Schubert, Prof. Dr.
  • Rostock, Germany, 18059
    • Recruiting
    • Klinikum Südstadt Rostock
    • Contact: Beate Krammer-Steiner, Dr.
  • Schkeuditz, Germany, 04435
    • Recruiting
    • Medcenter Nordsachsen
    • Contact: Leanthe Braunert, Dr.
  • Schwedt/Oder, Germany, 16303
    • Recruiting
    • Asklepios Klinikum Uckermark
    • Contact: Axel Matzdorff, Prof. Dr.
  • Schwetzingen, Germany, 68723
    • Recruiting
    • MVZ am Schlossgarten, Zero Praxen
    • Contact: Christian Kuhn, Dr.
  • Soest, Germany, 59494
    • Recruiting
    • Onkologiezentrum Soest/Iserlohn
    • Contact: Anke Wortmann, Dr.
  • Ulm, Germany, 89081
    • Recruiting
    • Bundeswehrkrankenhaus Ulm
    • Contact: Matthias Müller, Dr.
  • Villingen-Schwenningen, Germany, 78052
    • Recruiting
    • Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH
    • Contact: Paul La Rosée, Prof. Dr.
  • Wolfsburg, Germany, 38440
    • Recruiting
    • Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH
    • Contact: Thomas Gabrysiak, Dr.
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitätsklinikum Würzburg
    • Contact: Thomas Bumm, Dr.
  • Zittau, Germany, 02763
    • Recruiting
    • Praxis für Hämatologie und Internistische Onkologie
    • Contact: Mathias Schulze, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Novartis; Amgen; Grifols Biologicals, LLC; argenx; Swedish Orphan Biovitrum; University Hospital Dresden
• Investigators: Study Director: Thomas Stauch, Dr. med., Jena University Hospital; Study Director: Karolin Trautmann-Grill, Dr. med., Dresden Univeristy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: ZKSJ0142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No