ITP Registry and Accompanying Biospecimen Collection

Recruiting

• 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study Start: 2021-11-29
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-09
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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 & 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 (64)

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

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Praxis für Hämatologie und Onkologie Berlin-Mitte; 🇩🇪 Berlin, Germany

Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain; 🇩🇪 Berlin, Germany

Onkologie am Segelfliegerdamm; 🇩🇪 Berlin, Germany

MVZ Hämatologikum GmbH; 🇩🇪 Biberach, Germany

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