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Brief Title: Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
Official Title: High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes
Study ID: NCT05899751
Brief Summary: This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer. The study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. The study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. The study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital, Marseille, , France
University of Milan-Bicocca, Monza, , Italy
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), Barcelona, , Spain
Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO), Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Name: Carmelo Rizzari, MD
Affiliation: University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation
Role: PRINCIPAL_INVESTIGATOR