Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,524
- 试验地点
- 1
- 主要终点
- Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
研究概览
简要总结
This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.
详细描述
This is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects: 1500. Demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. Data captured will be analysed and presented using statistical tools.
OBJECTIVES:
Primary objective:
- To record the prevalence of KRAS mutations in the Argentine mCRC population.
Secondary objective:
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have signed written informed consent before any study-related procedure
- •Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1
- •Subjects with age above 21 years
- •Subjects willing to provide information required by protocol
- •No previous systemic treatment for mCRC
排除标准
- •Subjects with known pregnancy
- •Subjects with previous systemic therapy for mCRC
- •Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study
- •Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent
结局指标
主要结局
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
时间窗: Initial visit (Day 1) and subsequent visit till the end of the study
次要结局
- Subject and tumour characteristics and their association with KRAS mutational status(Initial visit (Day 1) and subsequent visit till the end of the study)