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临床试验/NCT01598597
NCT01598597已完成不适用

An Observational Pilot Study Evaluating the Feasibility of Conducting Genome-Wide Association Studies Utilizing Subject Provided Information in Subjects With Locally Recurrent or Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Non-Squamous Non-Small Cell Lung Cancer, Recurrent Glioblastoma, or Metastatic Renal Cell Cancer Treated With Avastin

Genentech, Inc.0 个研究点目标入组 276 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
入组人数
276
主要终点
Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)

研究概览

简要总结

This pilot, non-interventional, observational, Web-based, prospective cohort study is designed to collect self-reported safety and effectiveness and genetic data from subjects with locally recurrent breast cancer (BC) or metastatic breast cancer (MBC), metastatic colorectal cancer (MCRC), metastatic non-squamous non-small cell lung cancer (MNSCLC), recurrent glioblastoma (RGBM), or metastatic renal cell cancer (MRCC) in the United States who have been previously treated with Avastin (bevacizumab). The cohort will be composed of male and female subjects who have been diagnosed with locally recurrent BC or MBC, MCRC, MNSCLC, RGBM, or MRCC who have received treatment with bevacizumab in combination with chemotherapy, which started prior to or up to 31 December 2012. Participants will be self-referred to this study. They will be recruited online via a number of sources, including through the involvement of patient advocacy groups, social media tools, traditional media, physicians, and events to raise awareness of this study. After appropriate informed consent and authorization are obtained, data will be collected directly from subjects in an online survey. Participants will be contacted electronically to complete quarterly follow-up surveys. The follow-up period will be 1 year from responding to the baseline survey. DNA collection will be performed as part of this study. DNA will be extracted from saliva, which will be provided by the subject utilizing a collection kit sent to the participants for at-home use.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Locally recurrent BC or MBC, MCRC, MNSCLC, RGBM, or MRCC in patients treated or on treatment with bevacizumab, which started prior to or up to 31 December 2012
  • Ability to read and understand English
  • Ability to access and use a computer connected to the Internet
  • Signed informed consent and authorization form
  • Residence in the United States
  • At least 18 years of age

排除标准

  • 未提供

结局指标

主要结局

Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)

时间窗: 24 months

次要结局

  • Clinical characteristics (current disease status/previous treatments) of subjects participating in this study(24 months)
  • Demographic distribution (age, sex) of subjects participating in this study(24 months)

研究者

申办方类型
Industry
责任方
Sponsor

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