Health Condition 1: C96Z- Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above or equal to 18 years 2. Patients with a confirmed diagnosis of a malignancy (e.g., osteosarcoma, lymphoma, leukaemia) requiring HD-MTX (0.5 g/m2) therapy as part of standard routine care. 3. Patients undergoing routine TDM as per clinical protocol. 4. Patients who are willing to and able to give informed consent for genetic testing.
Exclusion criteria
Exclusion criteria: 1. Inadequate blood sample to carry out genetic testing. 2. Decline to participate in the genetic component of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of a population pharmacokinetics (pop-PK) model for patients undergoing HD-MTX therapy.Timepoint: 80 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between genotypes (SLC19A1, MTHFR) and incidence and severity of MTX induced toxicities.Timepoint: 24 weeks;Incidence of therapeutic failure / delay in reaching target MTX concentrationTimepoint: 0week to 104 weeks | — |
Countries
India
Contacts
Kasturba Medical College, Manipal