STEP 2 0: Rare Tumours in Children and Adolescents (STEP)

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05773651

Collaborator

(none)

10,000

Enrollment

Location

383.7

Anticipated Duration (Months)

26.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rare Diseases	Other: Data collection

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Jan 1, 2050

Anticipated Study Completion Date :

Jan 1, 2055

Arms and Interventions

Arm	Intervention/Treatment
Rare tumor disease Prospective epidemiological and clinical data collection of subjects with diagnosis of a rare solid tumor.	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

Arm

Intervention/Treatment

Rare tumor disease

Prospective epidemiological and clinical data collection of subjects with diagnosis of a rare solid tumor.

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

Outcome Measures

Primary Outcome Measures

Event-free survival [5 years]
Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tübingen	Tübingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Study Director: Ines Brecht, PD Dr. med., University Hospital Tübingen
Study Director: Dominik Schneider, Prof. Dr. med., Clinic for Pediatric and Adolescent Medicine at Dortmund Hospital