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A study in cancer patients to make high-dose methotrexate treatment safer using blood tests and genetic tests

Therapeutic Drug Monitoring and Pharmacogenomics Guided Population Pharmacokinetic Modelling of High-Dose Methotrexate in Karnataka, India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099239
Enrollment
90
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C96Z- Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: NIL: NIL

Sponsors

Nitisha Baruah
Lead Sponsor

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

MeasureTime frame
Development of a population pharmacokinetics (pop-PK) model for patients undergoing HD-MTX therapy.Timepoint: 80 weeks

Secondary

MeasureTime 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

Public ContactDr Jeffrey Pradeep Raj

Kasturba Medical College, Manipal

jeffrey.raj@manipal.edu7904286189

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026