Rare Tumours in Children and Adolescents (STEP)

NCT05773651 | Recruiting

• 1 other identifier: STEP 2.0
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rare Diseases

Keywords

Epidemiological data collection; Rare tumors in children; Rare tumors in adolescents; Clinical data collection

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Period between study entry and failure of induction therapy, recurrence or death from any cause is measured.

  5 years

Study Arms (1)

Rare tumor disease

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

Other: Data collection

Interventions

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

Rare tumor disease

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Rare Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

Central Study Contacts

Ines Brecht, PD Dr. med.

CONTACT

+49 7071 29; ines.brecht@med.uni-tuebingen.de

Michael Abele, Dr. med.

CONTACT

+49 7071 29; michael.abele@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: January 11, 2023
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2055
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after analysis and unlimited.

Locations

DE (1)