Last updated on August 2018

European Low and Intermediate Risk Neuroblastoma Protocol


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
  • Age: Between 1 - 18 Years
  • Gender: Male or Female

  1. LOW RISK STUDY

Inclusion criteria for the whole low risk group:

  • informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
  • Biopsy proven neuroblastoma
  • Tumour genomic profile obtained in a NRL according to guidelines
  • MYCN non-amplified

Exclusion criteria for the whole low risk group:

  • Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2

Inclusion criteria:

*age 18 months

Exclusion criteria:

  • any metastatic site
  • MYCN amplification
  • age > 18 months INRG Stage Ms

Inclusion criteria:

  • age 12 months

Exclusion criteria:

  • bone, pleura/lung and/or CNS metastasis
  • MYCN amplification
  • age > 12 months 2. INTERMEDIATE RISK STUDY

Inclusion criteria for the whole intermediate risk group:

  • informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
  • Tumour material available for biological studies according to guidelines
  • Biopsy proven neuroblastoma confirmed in a National Reference Laboratory (NRL)

Exclusion criteria for the whole intermediate risk group:

  • Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed

INRG Stage L1 and INSS stage 1:

Inclusion criteria:

  • MYCN amplified

Exclusion criteria:

  • MYCN non-amplified
  • INSS stages 2, 3, 4, 4s

INRG Stage L2:

Inclusion criteria:

  • Histology: differentiating, poorly differentiated, undifferentiated neuroblastoma or ganglioneuroblastoma nodular
  • MYCN non-amplified
  • age >18 months

Exclusion criteria:

  • neuroblastoma NOS
  • MYCN amplification.
  • age 18 months

INRG Stage M:

Inclusion criteria:

  • Any histology
  • MYCN non-amplified
  • age 12 months

Exclusion criteria:

  • MYCN amplification
  • age > 12 months 3. NEONATAL SUPRARENAL MASSES

Inclusion criteria:

  • Age less than or equal to 90 days when the suprarenal mass is discovered.
  • Suprarenal mass detected by ultrasound and/or MRI. The suprarenal mass may be cystic and/or solid, but IT CANNOT REACH THE MIDLINE AND should MEASURE 5 CM AT THE LARGEST DIAMETER.
  • No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland.
  • No metastatic involvement.
  • Frozen plasma available.
  • Informed consent.
  • Availability to do the adequate follow-up

Exclusion criteria:

  • Age older than 90 days.
  • Suprarenal mass bigger than 5 cm.
  • Regional involvement.
  • Metastatic involvement.
  • Inability to undertake mandatory diagnostic studies (biological markers, US, MRI, MIBG).
  • Follow-up not guaranteed by parents/guardians.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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