Relation of Genetic Polymorphism of ABCG2 Gene And Occurrence of Oxaliplatin - Induced Peripheral Neuropathy in Patients With Gastrointestinal Tract Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
研究概览
简要总结
This study will examine DNA from Gastrointestinal Tract of cancer patients treated with oxaliplatin to look for a variation (mutation) of the ABCG2 gene that may lead to drug-induced peripheral neuropathy in certain patients.
The DNA will be extracted from patients' blood samples and are analyzed for the ABCG2 single nucleotide polymorphism (G34A - rs2231137 and A/A -rs3114018 genotypes) and correlated with peripheral neuropathy grades.
详细描述
Pharmacogenetic analysis/genotyping :
Genotyping is conducted via High Resolution Melting (HRM) TECHNIQUE, To confirm the genotyping results, the Polymerase chain reaction (PCR) product of the samples will be examine via direct sequencing using 3500 Genetic analyzer from ThermoFisher (applied biosystem) at two ABCG2 loci using the following PCR primers:
1-ABCG2 G34A - rs2231137
Forward :
5'-TGC AAT CTC ATT TAT CTG GAC TA-'3
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastrointestinal Tract Cancer patients treated with Oxaliplatin-containing chemotherapy
- •Measurable disease
- •Age of 18 years to 80 years
排除标准
- •Pregnant women
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oxaliplatin.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Neurologic disease or patients with disease impairing the neurologic function affecting
结局指标
主要结局
Correlation of single nucleotide polymorphisms of ABCG2 gene (G34A - rs2231137 and A/A -rs3114018 genotypes) with peripheral neuropathy grades, using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE)
时间窗: After 6 cycles of chemotherapy (each cycle is15 days), for six months
Peripheral Neuropathy Toxicity will be assessed every cycle for six months using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE). Patients will be assigned to 4 groups according to the grades of neuropathy.
次要结局
未报告次要终点
研究者
Inas M Ahmed, PH
African Union,organization St. Abbsia, Cairo, Egypt
Ain Shams University