Neuropathic pain in patients undergoing anti-GD2 therapy for neuroblastoma. Cancer
Conditions
Interventions
This non-intervention, multi-centre, observational study will investigate the mechanisms contributing to pain in patients receiving anti-GD2 monoclonal antibodies. Patients receiving dinutuximab beta
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with high-risk neuroblastoma 2. Scheduled to undergo treatment with dinutuximab beta 3. A parent/guardian willing and able to give informed consent for participation in the study, if under 16 4. In the Investigator’s opinion, is able and willing to comply with all study requirements
Exclusion criteria
Exclusion criteria: An individual may not enter the study if ANY of the following apply: 1. Patients with moderate to severe pain from other causes that may confound assessment or reporting of pain from events such as recent severe injury. 2. Patients with concurrent severe psychological or psychiatric disorders. 3. Any other significant disease or disorder which, in the opinion of the Principal Investigator, may either put the patients at risk because of participation in the study, or may influence the result of the study, or the individual’s ability to participate in the study. 4. Patients who are in the opinion of the Principal Investigator unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in immune cell abundancies in peripheral blood measured using flow cytometry will be correlated with measures of pain using the Modified Objective Pain Score (KUSS, MOPS) (pre-verbal) or Revised Faces Pain Scale (verbal infants) before and after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in immune cell abundancies in peripheral blood measured using flow cytometry will be correlated with analgesic dosing measured using an electronic case report form (CRF) designed to gather data from the medical records as an indirect measure of pain before and after infusion 2. Neural damage measured using clinical assessment or molecular assay will be correlated with measures of pain using the Modified Objective Pain Score (KUSS, MOPS) (pre-verbal) or Revised Faces Pain Scale (verbal infants) before and after infusion 3. Patient clinical characteristics as recorded in the CRF will be correlated with measures of pain using the Modified Objective Pain Score (KUSS, MOPS) (pre-verbal) or Revised Faces Pain Scale (verbal infants) before and after infusion 4. Immune-related genetic sequencing (e.g. HLA type) will be correlated with clinical and diagnostic phenotypes at the individual patient level | — |
Countries
England, United Kingdom
Contacts
Public ContactAlexander Davies
Outcome results
None listed