An Observational Pilot Study Evaluating the Feasibility of Conducting Genome-Wide Association Studies Utilizing Subject Provided Information in Subjects With Locally Recurrent or MBC, MCRC, MNSCLC, RGBM or MRCC Treated With Avastin (Bevacizumab) (InVite)
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| First Received Date ICMJE | May 9, 2012 | ||||
| Last Updated Date | January 18, 2013 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01598597 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Observational Pilot Study Evaluating the Feasibility of Conducting Genome-Wide Association Studies Utilizing Subject Provided Information in Subjects With Locally Recurrent or MBC, MCRC, MNSCLC, RGBM or MRCC Treated With Avastin (Bevacizumab) (InVite) | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: saliva, optional blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Participants with history of metastatic or locally recurrent breast cancer treated with Avastin |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Cohort | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: N/A |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01598597 | ||||
| Other Study ID Numbers ICMJE | GO28289 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Genentech | ||||
| Study Sponsor ICMJE | Genentech | ||||
| Collaborators ICMJE | 23andMe, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | Genentech | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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