Status:
UNKNOWN
Biomarkers for Chemotherapy Associated Neurotoxicity
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Chemotherapy-Related Cognitive Impairment
Eligibility:
All Genders
4-25 years
Phase:
NA
Brief Summary
To assess if biomarkers can be used to predict early treatment related neurotoxicity in patients with Acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) and to inform development of n...
Detailed Description
Neurotoxicity during treatment for childhood ALL/LBL remains a significant problem. It can be acute as in the "stroke-like syndrome" seen with methotrexate, or may result in chronic neurocognitive def...
Eligibility Criteria
Inclusion
- Group 1 Inclusion Criteria
- Patients aged between 4-25 years inclusive at time of study consent (CogState is not validated for use in children aged \<4years).
- New diagnosis of ALL/LBL
- Informed written consent by patient or parent/guardian.
- Group 2 Inclusion Criteria - who experience an overt neurotoxic event
- Aged 1-25 at time of neurotoxic event
- Undergoing chemotherapy treatment for ALL/LBL
- Documented central neurological toxicity thought to be related to chemotherapy such as methotrexate stroke-like syndrome (SLS) Posterior reversible encephalopathy syndrome (PRES) or seizures with no clear alternative cause (see exclusion criteria below)
- Informed written consent by patient or parent/guardian
- Group 1 Exclusion Criteria
- Documented history of neurodevelopmental disorder prior to the diagnosis of ALL/LBL (e.g. Down syndrome, other chromosomal disorders).
- Significant visual impairment preventing computer use.
- Diagnosis of relapsed or second cancer.
- Active meningitis or seizures less than one month from study enrolment
- Patients whose Baseline line and Follow Up 1-4 \[FU1-4\] lumbar punctures will not be performed in a study centre
- Group 2 Exclusion Criteria
- Patients with cerebral venous sinus thrombosis as a cause of their neurological symptoms
- Patients whose symptoms are due to peripheral neuropathy or myopathy
- Patients with clear cause for neurological event unrelated to chemotherapy neurotoxicity e.g. head injury following trauma, acute meningitis, viral encephalitis with known causative organism, seizures secondary to severe electrolyte imbalance or hypoglycaemia
Exclusion
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05280262
Start Date
October 1 2015
End Date
July 31 2024
Last Update
March 15 2022
Active Locations (1)
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1
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom