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Influence of genetic modification on toxicities of Methotrexate in children with Leukemia

Not Applicable
Conditions
Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Registration Number
CTRI/2022/07/043817
Lead Sponsor
Sri Ramachandra Institute of Higher Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Pediatric patients diagnosed with Acute Lymphoblastic Leukemia

2. Both male and female patients between the age group of 0 -18 years

3. Patients who are categorized as high-risk, intermediate-risk, and relapse based on the protocol

4. Patients who are being prescribed Intravenous (I.V) Methotrexate (500mg/m2-5gm/m2)

Exclusion Criteria

1. Patients with other types of malignancies

2. Patients who are being prescribed oral Methotrexate

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The study will predict the genetic variant gene responsible for the development of methotrexate-induced toxicity in ALL patients, which will be useful in tailoring the doses of Methotrexate for this population.Timepoint: After 24 hrs of methotrexate administration genetic analysis will be carried out
Secondary Outcome Measures
NameTimeMethod
Serum concentration leading to Methotrexate induced toxicities will be identifiedTimepoint: Patients serum concentration will be estimated at baseline, after 24 and 48 hrs after Methotrexate administration
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