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

Recruiting

• Conditions: malignant tumor from the sympathetic nervous system; Neuroblastoma; 10029211

• Registration Number: NL-OMON51513
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois-CHUV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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 < 18 years at inclusion, male or female
• Ethic committee approval for each participating site
• Informed consent signed by the legal representatives and/or by the child
according to local regulations

Exclusion Criteria

• Renal insufficiency (creatinine clearance according to Schwartz formula <
60ml/min/m2)
• Absence of histological confirmation of high risk neuroblastoma
• Lack of consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity of plasma metanephrines (free and total MN, NMN, MTX), compared to<br /><br>standard evaluation procedures (urinary Dopamine, HVA, VMA) at diagnosis and<br /><br>end-of-induction in children with high risk neuroblastoma.</p><br>

Secondary Outcome Measures

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