High Dose Methotrexate Retrospective Registry
Research type
Research Study
Full title
High-dose methotrexate patterns of use, clearance, toxicities, supportive care and outcomes
IRAS ID
311786
Contact name
Madhumita Dandapani
Contact email
Sponsor organisation
Protherics Medicines Development Limited (PMDL) (BTG)
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Methotrexate is a chemotherapy drug that is used at high doses as part of routine care for many cancer patients. Methotrexate is associated with significant side effects and is removed from the body by the kidneys. If the kidneys can't remove the drug quickly enough, it can cause short- and long-term damage. This study will use data generated during the routine care of past patients (retrospective data collection) to evaluate high-dose methotrexate patterns of use, supportive care, clearance, toxicities, and outcomes.
We will identify best care practices and facilitate comparison with standards of care to identify gaps in care, concordance with best practices, and opportunities for improvement in supportive care of people receiving high-dose methotrexate. In addition, the registry will document and review the use of the methotrexate "rescue" drug, glucarpidase in order to collect available data on safety and efficacy.
The study will contribute to a larger multi-centre international study being conducted by Resonance Health on behalf of the sponsor BTG Specialty Pharma. Data will be collected from approximately 100 patient records on the paediatric oncology unit at the Queen's Medical Centre in Nottingham and shared with Resonance Health via an anonymised data entry portal to contribute to the larger study. The international study will then be analysed by Resonance Health to estimate the incidence of delayed and severely delayed methotrexate administration, estimate the incidence of acute kidney injury following methotrexate administration. It will also help to better understand variations in practice and outcome across different treating centres.
Ultimately, this project will allow the generation of better data on which to plan and monitor methotrexate dosing for patients with cancer, meaning that cancer doctors can use the drug more safely and amend dosing schedules to reduce the risk of severe complications for patients.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0100
Date of REC Opinion
13 Feb 2023
REC opinion
Favourable Opinion