The BioCAN Study Version 1.0
Research type
Research Study
Full title
Biomarkers and discovery of new therapeutic targets for chemotherapy associated neurotoxicity. (The BioCAN Study)
IRAS ID
262709
Contact name
Christina Halsey
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
19/SS/0041, Scotland A REC details (committee date 21/03/19)
Duration of Study in the UK
8 years, 1 months, 31 days
Research summary
Children with cancer are given combinations of chemotherapy drugs in high doses. Those with leukaemia are given chemotherapy specifically targeted to the brain in order to prevent recurrence at this site. Whilst these drugs give young patients the best chance of surviving their cancer, they are highly toxic and can damage developing brains. \n\nChildren treated with chemotherapy can show reduced IQ, reduced attention span and impaired memory. Neurocognitive impairment is estimated to occur in between 20-50% of long-term survivors and problems can continue to develop throughout adulthood. \n\nCurrently there is no way to predict which children will develop these neurological problems and there are no treatments to prevent or reduce them. Therefore, there is a need to determine what causes these problems and to understand which children are at risk so that new targeted therapies can be designed.\n\nThis UK-wide study will recruit 200 children and young people with acute lymphoblastic leukaemia and lymphoblastic lymphoma. \n\nPatients will complete a set of computer games designed to test ability to solve problems, reaction times and attention span. Test results will be analysed to see if subtle early changes in ability to perform these tasks predict long-term problems with learning and memory. \n\nLeftover samples of blood and cerebrospinal fluid (CSF), taken routinely during leukaemia treatment will be collected. The blood samples will be analysed for genetic differences in the way that different children’s brains deal with chemotherapy or repair damage, which may explain why only some children suffer brain side-effects. The CSF will be analysed to assess whether children with brain side-effects have higher levels of toxins or breakdown products of chemotherapy in the CSF which could be potentially be used as diagnostic tests or to develop antidotes in the future. \nClinical questionnaires and results of any clinical imaging tests will also be obtained. \n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0092
Date of REC Opinion
11 Jul 2019
REC opinion
Further Information Favourable Opinion