Rare Tumours in Children and Adolescents (STEP) | NCT05773651

Studies
Rare Tumours in Children and Adolescents (STEP)

NCT05773651

Sponsor

University Hospital Tuebingen

Status

Recruiting

Last Update Posted

Oct 1, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Rare Diseases

Interventions

Data collection

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2023Actual

Primary Completion Date

Jan 2050Estimated

Completion Date

Jan 2055Estimated

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2024

Last Update Posted Date

Oct 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

50 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rare tumor disease		Prospective epidemiological and clinical data collection of subjects with diagnosis of a rare solid tumor.	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children and adolescents with rare solid tumors from primary care clinic, university hospitals, specialty centers, ...

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ines Brecht, PD Dr. med.	Contact	+49 7071 29	81380	ines.brecht@med.uni-tuebingen.de
Michael Abele, Dr. med.	Contact	+49 7071 29	61837	michael.abele@med.uni-tuebingen.de

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tübingen	Recruiting	Tübingen		72076	Germany

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The STEP Register will provide data in a pseudonymised manner to national and international databases set up to optimize the diagnosis and treatment of rare tumors in children and adolescents

Types

Not provided

Time Frame

Data will become available after analysis and unlimited.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided