| NCT ID | NCT07410247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Childhood Myeloproliferative Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-01-01 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Myeloproliferative neoplasms (MPNs) are caused by defects in blood cell production. This leads to an overproduction of mature cells, such as red blood cells or platelets. As a result, clinical symptoms and complications can develop. Circulatory disorders and resulting pain symptoms, such as headaches, are the most prominent. Furthermore, blood clotting disorders can occur, leading to vascular occlusions or bleeding. Over a longer period, bone marrow transformation into fibrous tissue or the development of acute leukemia can occur, resulting in even more serious complications. In the vast majority of cases, MPNs are diagnosed in older adults. These diagnoses are extremely rare in children and adolescents. Therefore, clinical and genetic characteristics, treatment options, and outcomes in pediatric patients with MPNs are insufficiently described, and only limited data are available for standardizing diagnostic and therapeutic approaches for MPNs in childhood and adolescence. Recommendations and guidelines from the adult field, which have largely been adopted and applied to children and adolescents, do not adequately address the specific needs of patients in childhood and adolescence. To gain more insights into MPN during this early, vulnerable phase of life, we have established a nationwide registry in Germany that systematically collects data from children and adolescents with MPN. The registry focuses particularly on the scientific analysis of the biological characteristics and differences of MPN in children and adolescents compared to adults.
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed PV, ET, PMF or pHES * Age \< 18 years (up to 17 years and 365 days) at the day of diagnosis * Patient treated in a participating center * Written informed consent to registry participation Exclusion Criteria: o Secondary polycythemia, thrombocytosis, myelofibrosis or HES with underlying reasons other than PV, ET, PMF or pHES
Contact & Investigator
Axel Karow, MD
PRINCIPAL INVESTIGATOR
Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany
Frequently Asked Questions
Who can join the NCT07410247 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying Childhood Myeloproliferative Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07410247 currently recruiting?
Yes, NCT07410247 is actively recruiting participants. Contact the research team at axel.karow@uk-erlangen.de for enrollment information.
Where is the NCT07410247 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT07410247 clinical trial?
NCT07410247 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Axel Karow, MD at Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany. The trial plans to enroll 500 participants.