Clinical trial NCT05152238: ITP Registry and Accompanying Biospecimen Collection
Official title: Multicenter National ITP Registry and Accompanying Biospecimen Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Thrombocytopenia
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Dresden
name: Novartis
name: Swedish Orphan Biovitrum
name: Grifols Biologicals, LLC
name: Amgen
name: argenx
First posted: 2021-12-09
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: epidemiological data on ITP - Incidence
timeFrame: At enrollment
measure: epidemiological data on ITP - Age
timeFrame: At enrollment
measure: epidemiological data on ITP - Sex distribution
timeFrame: At enrollment
measure: Description of the causes of ITP
timeFrame: At enrollment
measure: ITP treatment type received
timeFrame: 5 years
measure: Remission
timeFrame: 5 years
Secondary outcomes:
measure: Recording of clinical characteristics of affected patients - Disease stage
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Recording of clinical characteristics of affected patients- platelet counts
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Recording of clinical characteristics of affected patients -disease manifestation at diagnosis
timeFrame: At enrollment
measure: Bleeding events
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: thromboembolic events
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Quality of Life questionaire
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: fatigue assessment
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Laboratory parameters ANA
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Laboratory parameters APL-Antibodies
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Laboratory parameters Lupus-Antibodies
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Laboratory parameters platelet autoantibodies
timeFrame: At enrollment, 6 months, annually up to 5 years
measure: Laboratory parameters helicobacter pylori
timeFrame: At enrollment, 6 months, annually up to 5 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen AöR
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie
city: Aschaffenburg
country: Germany
facility: MVZ am Klinikum Aschaffenburg
city: Bad Homburg
country: Germany
facility: MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus
city: Bad Liebenwerda
country: Germany
facility: Onkologie/Hämatologie
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain
city: Berlin
country: Germany
facility: Onkologie am Segelfliegerdamm
city: Biberach
country: Germany
facility: MVZ Hämatologikum GmbH
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Coburg
country: Germany
facility: MVZ Klinikum Coburg GmbH
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Donauwörth
country: Germany
facility: ARGE e.V.
city: Dresden
country: Germany
facility: Onkozentrum Dresden/Freiberg
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie-Onkologie
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Mohm & Prange-Krex
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Düren
country: Germany
facility: Krankenhaus Düren gGmbH
city: Erfurt
country: Germany
facility: Onkologische Praxis Erfurt
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Frankfurt am Main
country: Germany
facility: Haemostas-Frankfurt
city: Frechen
country: Germany
facility: PIOH Studien und Management GbR
city: Garbsen
country: Germany
facility: Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei
city: Gera
country: Germany
facility: IOGP Gera MVZ GmbH
city: Greifswald
country: Germany
facility: Universitätsklinik Greifswald
city: Göppingen
country: Germany
facility: ALB FILS Kliniken, Klinik am Eichert
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen gGmbH
city: Halle
country: Germany
facility: Gemeinschaftspraxis, FA für Innere Medizin
city: Halle
country: Germany
facility: MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH
city: Hamburg
country: Germany
facility: Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH
city: Hannover
country: Germany
facility: Werlhof-Institut MVZ GmbH
city: Hannover
country: Germany
facility: Onkologie am Raschplatz
city: Hannover
country: Germany
facility: Dres. Kamal & Dorn GbR
city: Heidenheim
country: Germany
facility: ODZ-Petersen GmbH
city: Hildesheim
country: Germany
facility: St. Bernward Krankenhaus GmbH
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH
city: Jena
country: Germany
facility: University Hospital Jena
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
city: Kronach
country: Germany
facility: Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung
city: Leer
country: Germany
facility: MVZ mbH, Onkologische Schwerpunktpraxis
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: OnkoFor Leipzig GmbH
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie
city: Merseburg
country: Germany
facility: Carl-von-Basedow Klinikum Merseburg
city: München
country: Germany
facility: Gemeinschaftspraxis Hämato-Onkologie
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum Neubrandenburg
city: Neustadt Am Rübenberge
country: Germany
facility: MVZ Onko Medical GmbH Neustadt
city: Offenburg
country: Germany
facility: Pi.Tri.-Studien GmbH
city: Riesa
country: Germany
facility: Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock
city: Schkeuditz
country: Germany
facility: Medcenter Nordsachsen
city: Schwedt/Oder
country: Germany
facility: Asklepios Klinikum Uckermark
city: Schwetzingen
country: Germany
facility: MVZ am Schlossgarten, Zero Praxen
city: Soest
country: Germany
facility: Onkologiezentrum Soest/Iserlohn
city: Ulm
country: Germany
facility: Bundeswehrkrankenhaus Ulm
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH
city: Wolfsburg
country: Germany
facility: Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zittau
country: Germany
facility: Praxis für Hämatologie und Internistische Onkologie
Study officials:
affiliation: Jena University Hospital
name: Thomas Stauch, Dr. med.
role: STUDY_DIRECTOR
affiliation: Dresden Univeristy Hospital
name: Karolin Trautmann-Grill, Dr. med.
role: STUDY_DIRECTOR
References: