Rare Tumours in Children and Adolescents (STEP)

Rekrutierend

NCT-Nummer:
NCT05773651

Studienbeginn:
Januar 2023

Letztes Update:
24.03.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Rare Diseases

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Studienleiter

Ines Brecht, PD Dr. med.
Study Director
University Hospital Tübingen

Dominik Schneider, Prof. Dr. med.
Study Director
Clinic for Pediatric and Adolescent Medicine at Dortmund Hospital

Kontakt

Ines Brecht, PD Dr. med.
Kontakt:
Phone: +49 7071 29
Phone (ext.): 81380
E-Mail: ines.brecht@med.uni-tuebingen.de» Kontaktdaten anzeigen

Michael Abele, Dr. med.
Kontakt:
Phone: +49 7071 29
Phone (ext.): 61837
E-Mail: michael.abele@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Tübingen
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ines Brecht, PD Dr. med.
Phone: +49 7071 29
Phone (ext.): 81380
E-Mail: ines.brecht@med.uni-tuebingen.de

Michael Abele, Dr. med.
Phone: +49 7071 29
Phone (ext.): 61387
E-Mail: michael.abele@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The objective of the STEP registry is to optimise the diagnosis and treatment of patients

with rare tumour diseases in childhood and adolescence. Therefore, a continuous prospective

collection of clinical data on rare paediatric tumours is conducted to improve the

understanding of these tumours. Beyond analysis of clinical data, further scientific research

on the biological and molecular genetic characteristics of these tumours is performed. These

data and a close collaboration with international partners, especially the European EXPeRT

group, enable the improvement of treatment recommendations for these tumours along with

establishment a global interdisciplinary network of rare tumour specialists.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of a rare solid tumor

- Age at diagnosis: Neonatal period to 18 years (In the case of young adults,

registration in the database and/or referral to advisory contact persons within the

framework of the competence network can take place upon request and after declaration

of consent.)

- Information, education, written consent of the patient or the guardian

- Not recorded in any of the existing clinical studies/ registers of the German Society

for Pediatric Oncology and Hematology (GPOH)

Exclusion Criteria:

- Registration of the tumor diagnosis in a prospective therapy study/ another clinical

registry of the GPOH

- Lack of information, explanation and/or written consent of the patient or the legal

guardian.

Studien-Rationale

Primary outcome:

1. Event-free survival (Time Frame - 5 years):
Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.

Geprüfte Regime

Data collection:
The data collection includes, among other things: Diagnosis of the rare tumor (pathological findings/ reference pathological findings), full name, birth date, gender, clinical registry inclusion and exclusion criteria met - yes / no, signed declaration of consent-yes / no, if yes: date of signature

Quelle: ClinicalTrials.gov