HR-NBL2

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

Patient Information Videos

Patient Information Videos

CCLG, in association with the trial, have created patient/parent-friendly videos to help explain neuroblastoma treatment and the HR-NBL2 trial. Please follow the YouTube links to view.

Introduction to High Risk Neuroblastoma – an informational video for parents and patients.

 

Information on Induction therapy for High Risk Neuroblastoma

Information on Stem Cell Harvest during treatment for High Risk Neuroblastoma

Information on Surgery during treatment for High Risk Neuroblastoma

Information on Consolidation therapy for High Risk Neuroblastoma

Information on Radiotherapy for High Risk Neuroblastoma Unlisted

Information on Maintenance therapy during treatment for High Risk Neuroblastoma

Information on What happens after treatment for High Risk Neuroblastoma

Trial Documents

Links to the current protocol, Patient Information Sheet and Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below.

If you cannot find what you are looking for please email the HR-NBL2 Trials Office.

Patient Documents

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control Log. Links to the current Version Control Lists used in this trial are below.

Amendments

Below are links to documents submitted as part of substantial protocol amendments for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

Case Report Form: The current version can be downloaded from the 'Documents' section of the Trial Master database

Pharmacovigilance reporting forms

Guidelines

Other Trial Documents


Change of Staff

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the HR-NBL2 Trial Office.

News and Events

Contact Details

Chief Investigator

Dr Dominique Valteau-Couanet

Institut Gustave Roussy
114 rue Edouard Vaillant
94 805 Villejuif
France

UK Lead Investigator

Dr Martin Elliott                                                                          

Consultant Paediatric Oncologist, Leeds General Infirmary

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Tel: +44 (0) 121 414 3799

Email: Martin Elliott

 

HR-NBL2 Trial Office

Trial Coordinator:  Hannah Jeffery / Salma Iqbal
Trial Administrator: Faiza Suleman
Senior Trial Coordinator:  Jennifer Laidler
Trial Management Team Leader:  Charlotte Firth

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

 Enquiries

Telephone: +44 (0) 121 414 3799 or +44 (0) 121 415 8211
Fax: +44 (0) 121 414 9520
Email: HighRisk-NBL2@trials.bham.ac.uk

Randomisation service supplied by the Sponsor Gustave Roussy, France

Randomisation should be performed by sites online at:

https://trials.siopen-r-net.org/ 

In case of any problems with online randomisation, contact the Trial Office.

 

Serious Adverse Event Reporting

SAE's should be Reported on the my-eclinical web portal:

https://www.evereport.eu/myeclinical/form/IGR/login.php

In case of any problems, email: reg@trials.bham.ac.uk and HighRisk-NBL2@trials.bham.ac.uk

 

Sponsor

Institut Gustave Roussy

CRCTU Home Page

http://www.birmingham.ac.uk/crctu