A Prospective Observational Study to Determine the Association of Genetic Polymorphisms with Serum Methotrexate Levels in Cancer Patients with Methotrexate Related Toxicities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Proportion of patients with C677T and A1298C MTHFR Genetic polymorphism in cases of Methotrexate toxicity as well as in controls (Grade 0).
研究概览
简要总结
| Methotrexate (MTX) |
| is frequently used to treat several illnesses, including inflammatory bowel |
| disease, rheumatoid arthritis, psoriasis, cancer, acute lymphoblastic |
| leukaemia or lymphoma, and hematopoietic cell transplantation. Methotrexate |
| has been shown to inhibit Methylene tetrahydrofolate reductase (MTHFR). The |
| intestinal epithelium and bone marrow are the main targets of MTX toxicity. Elevation |
| of transaminases could indicate hepatic toxicity, increasing the risk of |
| cirrhosis. MTX can also cause alopecia, dermatitis, allergic interstitial |
| pneumonitis, neurologic symptoms, changes in bone metabolism, |
| hyperhomocysteinemia, nephrotoxicity (after high-dose treatment), abortion, |
| teratogenesis, impaired oogenesis or spermatogenesis. Two genetic variations |
| can lower MTHFR’s enzyme function, namely, rs1801133 (C677T) and |
| rs1801131 (A1298C). |
Therefore, this study is being planned in the South Indian Population to determine the serum concentrations of Methotrexate and the genetic polymorphisms associated with it, in oncology patients receiving Methotrexate chemotherapy and presenting with toxicity.
The study aims to investigate the influence of genetic polymorphisms on serum concentrations of Methotrexate, methotrexate induced toxicities in cancer patients receiving Methotrexate chemotherapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Patients with various cancers undergoing MTX chemotherapy, receiving Methotrexate at a dose of more than 500 mg
- •Age: Above 18 years and less than 65 years
- •Gender: Male and Female
- •Those who are willing to give written informed consent.
排除标准
- •Pregnancy and lactation.
- •History of a drug reaction or allergy to Methotrexate.
结局指标
主要结局
1. Proportion of patients with C677T and A1298C MTHFR Genetic polymorphism in cases of Methotrexate toxicity as well as in controls (Grade 0).
时间窗: 24, 48, and 72 hours
2. Correlation of C677T and A1298C MTHFR Genetic Polymorphism with Serum Levels of Methotrexate.
时间窗: 24, 48, and 72 hours
次要结局
- The correlation between genetic polymorphism and hematologic and non-hematologic toxicities.(24, 48, and 72 hours)
研究者
Siddhartha Krishna Deka
Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences