Biomarkers for Chemotherapy Associated Neurotoxicity

NCT05280262 | Unknown

• 1 other identifier: GN18ON516P
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 novel interventions.

Conditions

Chemotherapy-Related Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Group 1 - Change in CogState aggregated test score between test points 1 and 4

  measure of cognitive decline over time

  2 years

• Group 1 - Change in CSF Homocysteine levels over time

  Downstream metabolite thought to be responsible for neurotoxic effects of chemotherapy

  2 years

Study Arms (2)

Group 1 Asymptomatic

OTHER

Group 1 - Prospective cohort of children and young adults enrolled at diagnosis and followed longitudinally Patients will be evaluated at 5 time-points (Baseline - Follow Up 1-4 \[FU1-4\]) during therapy using a computer-based short age-appropriate neurocognitive test battery (CogState) and paired CSF samples taken at the time of routine scheduled lumbar punctures. In addition one saliva sample (or stored DNA from a remission bone marrow sample extracted during routine trial procedures) will be collected as a source of germline DNA and a clinical report form will be completed at study entry and at completion of the study. CSF samples will be collected at the time of the patient's scheduled therapeutic treatment with no additional sampling.

Diagnostic Test: CogState Test

Group 2 Symptomatic

OTHER

Group 2 - Children and young adults with Stroke-like syndrome/PRES and /or seizures (SPS) Following a diagnosis of SPS, patients and their families can be approached for informed consent to enter this study within 4 weeks following SPS event. If consent is obtained, patients will be evaluated at up to 7 timepoints, or until end of treatment, using a computer-based short age-appropriate neurocognitive test battery (CogState) and paired CSF samples taken at the time of routine scheduled lumbar punctures. Follow up visit 2 will take place at 12 months, with Follow up 3-7 \[FU3-7\] scheduled at 6 monthly timepoints. CSF samples will be collected at the time of the patient's scheduled therapeutic treatment with no additional sampling.

Diagnostic Test: CogState Test

Interventions

CogState Test DIAGNOSTIC_TEST

Computerized cognitive testing which provides a score/measurement of distinct cognitive functions

Group 1 Asymptomatic; Group 2 Symptomatic

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Aged 1-25 at time of neurotoxic event
• Undergoing chemotherapy treatment for ALL/LBL

You may not qualify if:

• Informed written consent by patient or parent/guardian
• 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
• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Christina Halsey, Dr

CONTACT

+44 141 330 8135; chris.halsey@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No blinding on trial
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: March 15, 2022
• Study Start: October 1, 2015
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)