UMBRELLA

Author:  Julia Dobke, erstellt am 2021/12/08, Last modification:  2021/12/15

UMBRELLA

UMBRELLA PROTOCOL SIOP-RTSG 2016

Disease

Kidney tumors

Type

Prospective, international, non-randomized trial

Problem / Objectives

Overall aim

The overall aim of the SIOP 2016 UMBRELLA protocol is to harmonize the clinical relevant standard diagnostic procedures for all paediatric renal tumours within SIOP and to provide imaging studies and biomaterial from all of these patients, to find new and better risk factors for treatment stratification and molecular targets for novel therapeutic approaches. This will help to improve short and long term outcomes for all children with renal tumours through the introduction of a more ‘personalised’ approach.

Primary objectives

  • To show the feasibility of storing serial blood, urine samples, tumour and germline material at diagnosis and at specific time points during treatment for international collaborative studies.
  • 1q gain and genomic copy number biomarkers: To assess genomic 1q gain as a prognostic biomarker in WT.
  • Volume of blastema: To optimise the definition of high risk WT, ‘blastemal type’.
  • Radiology review: To optimise radiological diagnostics by (real time) central review.
  • Pathology review: To optimise pathological diagnostics by (real time) central review.
Inclusion Criteria

All children, adolescents or young adults with a primary or relapsed renal tumour diagnosed in a participating SIOP-RTSG centre are eligible for inclusion in the SIOP 2016 UMBRELLA study.

Exclusion Criteria

The only exclusion criterion is missing informed consent.

Status Start 2021, End: until further notice
EudraCT 2016-004180-39
Entry Study Register Deutsches Krebsstudienregister: DKR-ID DRKS00011208
Principal Investigator Prof. Dr. med.Norbert Graf
Contact

Principal Investigator Germany

Prof. Dr. med. Norbert Graf Universitätsklinikum des Saarlandes Klinik für Pädiatrische Onkologie und Hämatologie 66421 Homburg/Saar Telefon +49 (6841) 1628 397 Fax +49 (6841) 1628 302 Norbert.Graf@uks.eu

Participants 43 contries worldwide, 500 patients in the GPOH