跳至主要内容
临床试验/NCT01652833
NCT01652833已完成不适用

Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing

Amgen0 个研究点目标入组 453 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Amgen
入组人数
453
主要终点
Proportion of oncologists who are aware of the correct indication of Vectibix, with regard to tumor KRAS status and who conduct a KRAS test prior to initiation of Vectibix treatment

研究概览

简要总结

To ensure the appropriate administration of Vectibix for the treatment of mCRC with wild-type KRAS in real-world practice, it is important to understand the awareness of practicing oncologists regarding the correct indication and appropriate administration of Vectibix. It is also critical to monitor changes in oncologists' awareness and practice between the different rounds of the study.

详细描述

The survey will be conducted for 3 rounds in months 0, 12, and 24 after the first interview.

Before the beginning of each round, a sampling list will be created by Amgen.

In each round of the survey, potential participating oncologists will be sampled from each country's sampling list through random sampling and reached through telephone, letter or email. During the initial contact, the oncologists will be assessed for their eligibility to participate in the study by using a standardized screening questionnaire.

The initial contact and screening of potential participating oncologists will continue until a total of 150 eligible oncologists agree to participate in each round. The number of oncologists sampled in each country will be proportional to the use of Vectibix in each country and the number of oncology physicians estimated to prescribe Vectibix. Each eligible oncologist can only participate in 1 of the 3 rounds of survey.

Study staff will then conduct the survey with each of the identified eligible oncologists over the telephone, using a standardized questionnaire. Information about their awareness of the correct indication and appropriate administration of Vectibix and their experience in the administration of Vectibix treatment in the previous 6 months will be collected. We will make every attempt to collect the correct information from participating oncologists. This may require at least two phone calls to allow an oncologist to review their notes in order to report the correct data.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be a practicing oncology specialist
  • Must treat at least 3 new or continuing patients with metastatic colorectal cancer in the last quarter
  • Must have prescribed Vectibix within the last 6 months to metastatic colorectal cancer patients

排除标准

  • Must not have taken part in this study previously
  • Must not have participated in Amgen study number 20101120.

结局指标

主要结局

Proportion of oncologists who are aware of the correct indication of Vectibix, with regard to tumor KRAS status and who conduct a KRAS test prior to initiation of Vectibix treatment

时间窗: Trend survey of physicians performed over 3 years

Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatment

时间窗: Trend survey of physicians performed over 3 years

Proportion of oncologists who administer Vectibix in mCRC patients with mutant KRAS tumors or with KRAS status unknown

时间窗: Trend survey of physicians performed over 3 years

Proportion of oncologists who administer Vectibix simultaneously with oxaliplatin-containing chemotherapy in mCRC patients with mutant KRAS tumors or patients with tumor KRAS status unknown

时间窗: Trend survey of physicians performed over 3 years

次要结局

未报告次要终点

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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