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Genetic Polymorphism and Methotrexate Toxicities

A Prospective Observational Study to Determine the Association of Genetic Polymorphisms with Serum Methotrexate Levels in Cancer Patients with Methotrexate Related Toxicities - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094960
Enrollment
100
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site

Interventions

Intervention1: Methotrexate Infusion: Injection of Methotrexate will be administered as per the standard treatment protocol for the type of cancer by the treating physician

Sponsors

Siddhartha Krishna Deka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with various cancers undergoing MTX chemotherapy, receiving Methotrexate at a dose of more than 500 mg 2. Age: Above 18 years and less than 65 years 3. Gender: Male and Female 4. Those who are willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation. 2. History of a drug reaction or allergy to Methotrexate.

Design outcomes

Primary

MeasureTime frame
1.Proportion of patients with C677T and A1298C MTHFR Genetic polymorphism in cases of Methotrexate toxicity as well as in controls (Grade 0). 2.Correlation of C677T and A1298C MTHFR Genetic Polymorphism with Serum Levels of Methotrexate. Timepoint: 24, 48, and 72 hours

Secondary

MeasureTime frame
The correlation between genetic polymorphism and hematologic and non-hematologic toxicities.Timepoint: 24, 48, and 72 hours

Countries

India

Contacts

Public ContactDr C Prabhakar Reddy

Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences

cptnims@gmail.com7416512888

Outcome results

None listed

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