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UMBRELLA PROTOCOL SIOP-RTSG 2016 Integrated research and guidelines for standardized diagnostics and therapy for paediatric renal tumours

UMBRELLA PROTOCOL SIOP-RTSG 2016 Integrated research and guidelines for standardized diagnostics and therapy for paediatric renal tumours - UMBRELLA PROTOCOL SIOP-RTSG 2016

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54547
Enrollment
1050
Registered
2019-02-25
Start date
2019-06-07
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nefroblastoma Wilms tumour

Interventions

None listed

Sponsors

Universität des Saarlandes
Lead Sponsor

Eligibility

Age
No minimum to 64 Years

Inclusion criteria

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

Exclusion criteria: The only exclusion criterion is missing informed consent.

Design outcomes

Primary

MeasureTime frame
Study parameters: - 1q gain and other copy number variants - Radiological parameters (including diffusion-weighted imaging, DWI) for histological subtype - Blastemal volume Outcome: - Overall survival - Event-free survival - Relapse-free survival

Secondary

MeasureTime frame
Study parameters: - Mutations in individual known Wilms tumour genes (including WT1, CTNNB1, AMER1, TP53, MYCN, FBXW7, GPC3, MLLT1, DIS3L2, DICER1, DROSHA, DGCR8, SIX1 and SIX2) - miRNA as biomarker in blood, urine and tumour samples Outcomes: - Overall survival - Event-free survival - Relapse-free survival

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)