A prospective observational study to determine the influence of the UGT1A1 gene polymorphism on the safety profile of IRINOTECAN in cancer patients in a tertiary care centre in South India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 3
研究概览
简要总结
This prospective observational study aims to evaluate the influence of UGT1A1 gene polymorphism on the safety profile of irinotecan in cancer patients receiving treatment at a tertiary care centre in South India. Irinotecan is commonly associated with dose-limiting toxicities such as neutropenia and diarrhea, and genetic variations in the UGT1A1 gene are known to affect its metabolism.
Eligible cancer patients scheduled to receive irinotecan as part of standard chemotherapy will be enrolled following the acquisition of informed consent. Peripheral blood samples will be collected for UGT1A1 genotyping. Patients will be prospectively monitored for the development and severity of adverse drug reactions, particularly hematological and gastrointestinal toxicities. Adverse events will be graded using standard toxicity criteria.
The primary objective is to assess the association between UGT1A1 polymorphism and incidence of severe irinotecan-related toxicities. The findings may help identify patients at increased risk of adverse effects and contribute to safer, individualized chemotherapy in routine clinical practice.
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)（—）
- 性别
- All
入选标准
- •Adult patients (greater than 18 years) with histologically or cytologically confirmed colorectal cancer, pancreatic cancer, or small cell lung cancer who are scheduled to receive or currently receiving an irinotecan-based chemotherapy regimen (e.g., FOLFIRI, FOLFOXIRI, FOLFIRINOX).
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–
- •Patients with adequate baseline organ function as per institutional protocol as defined by Absolute neutrophil count (ANC) greater than or equal to 150 per cu.
- •mm Platelet count greater than or equal to 100,000 per cu.
- •mm White blood cell count greater than or equal to 3000 per cu.
- •mm Serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN) and transaminases less than or equal to 2.5 times ULN (less than or equal to 5 times ULN if liver metastases are present) Creatinine clearance greater than or equal to 50 mL per min (calculated by Cockcroft–Gault or institutional method) 4) Patients willing and able to provide written informed consent for participation and genetic testing (UGT1A1 genotyping).
- •Patients residing in South India and able to understand study-related instructions in the local language to ensure compliance with follow-up.
排除标准
- •Pregnant or lactating women.
- •Patients unwilling or unable to provide written informed consent.
- •Patients with inadequate baseline hematological, hepatic, or renal function as defined in the inclusion criteria.
- •Patients with uncontrolled comorbidities (e.g., unstable cardiac disease, uncontrolled hypertension, uncontrolled diabetes) or active infections that may interfere with study participation or irinotecan administration, in the investigator’s judgment.
- •Prior severe hypersensitivity reaction to irinotecan or other components of the planned chemotherapy regimen.
研究者
Dr Irragam reddy Rahul reddy
Sri venkateswara institute of medical sciences and research- SPMCW