Rare Tumours in Children and Adolescents (STEP)

Rare Diseases Clinical Trial

— STEP 2 0  

Official title:

Rare Tumours in Children and Adolescents (STEP 2.0) - Register for the Documentation of Rare Tumours in Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773651
• Other study ID #: STEP 2.0
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: January 2055

Study information

• Verified date: March 2023
• Source: University Hospital Tuebingen
• Contact: Ines Brecht, PD Dr. med.
• Phone: +49 7071 29
• Email: ines.brecht[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the STEP registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. The rarity of a disease should not be a disadvantage for the young patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2055
• Est. primary completion date: January 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rare Diseases

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.	5 years

External Links

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