International multicenter observational study to determine the diagnostic sensitivity of plasma metanephrines and urinary catecholamines and metabolites compared to standard evaluation procedures in children with high risk neuroblastoma

International multicenter observational study to determine the diagnostic sensitivity of plasma metanephrines and urinary catecholamines and metabolites compared to standard evaluation procedures in children with high risk neuroblastoma - Metanephrines

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51513

Enrollment

Registered

2022-06-16

Start date

2022-07-18

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

malignant tumor from the sympathetic nervous system Neuroblastoma

Interventions

None listed

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: • Patients with confirmed high risk neuroblastoma (clinical and/or biological) • Patients treated within or according to SIOPEN HR-NBL-2 clinical trial • Age

Exclusion criteria

Exclusion criteria: • Renal insufficiency (creatinine clearance according to Schwartz formula

Design outcomes

Primary

Measure	Time frame
Sensitivity of plasma metanephrines (free and total MN, NMN, MTX), compared to standard evaluation procedures (urinary Dopamine, HVA, VMA) at diagnosis and end-of-induction in children with high risk neuroblastoma.	—

Secondary

Measure	Time frame
• Sensitivity of plasma metanephrines (free and total MN, NMN, MTX) compared to eight metabolites (VMA, HVA, 3MT, dopamine, E, MN, NE and NMN) in urine at diagnosis and end-of-induction in children with high risk neuroblastoma. • Sensitivity of plasma metanephrines (free and total) compared to other gold standard diagnostic and monitoring tools (MRI, MIBG scan, bone marrow evaluation), at diagnosis and end-of-induction. • Sensitivity of free and total plasma metanephrines and urinary catecholamines and metabolites at end of induction in correlation to age at diagnosis, disease stage, histology and molecular characteristics.	—

Measure

Time frame

• Sensitivity of plasma metanephrines (free and total MN, NMN, MTX) compared to eight metabolites (VMA, HVA, 3MT, dopamine, E, MN, NE and NMN) in urine at diagnosis and end-of-induction in children with high risk neuroblastoma. • Sensitivity of plasma metanephrines (free and total) compared to other gold standard diagnostic and monitoring tools (MRI, MIBG scan, bone marrow evaluation), at diagnosis and end-of-induction. • Sensitivity of free and total plasma metanephrines and urinary catecholamines and metabolites at end of induction in correlation to age at diagnosis, disease stage, histology and molecular characteristics.

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Countries

Netherlands

Outcome results