Prospective multicenter clinical trial for risk estimation and treatment stratification in low and intermediate risk neuroblastoma patients (NB2015-LR)

Phase 1

• Conditions: euroblastoma, low or intermediate risk; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004883-37-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

•Neuroblastoma diagnosed according to the INSS criteria
•MYCN not amplified
•Localized neuroblastoma INRGSS stage L1 or L2 / INSS stage 1-3 and age =18 months –and < 21 years OR INRGSS stage MS/INSS 4S OR INSS Stage 4/INRGSS stage M and age <18 months OR ptients with relapse/progression of localized neuroblastoma <18 months of age at first diagnosis
•Sufficient tumor material in good quality from initial diagnosis available for analysis of RNA expression array
•informed consent of guardians and/or the patient (depending on age)

Are the trial subjects under 18? yes
Number of subjects for this age range: 275
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Participation in other trials, which might interfere with NB2015-LR
•Pregnancy, lactation, or insufficient contraception for girls in childbearing age,
•Any concomitant non-protocol anticancer therapy,
•Incomplete initial staging

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified