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)
1 other identifier
observational
276
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMay 8, 2015
May 1, 2015
2.7 years
May 9, 2012
May 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)
24 months
Secondary Outcomes (2)
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
Study Arms (1)
Cohort
Eligibility Criteria
Participants with history of metastatic or locally recurrent breast cancer treated with Avastin
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- 23andMe, Inc.collaborator
Study Sites (50)
Unknown Facility
Many Locations, Alabama, United States
Unknown Facility
Many Locations, Alaska, United States
Unknown Facility
Many Locations, Arizona, United States
Unknown Facility
Many Locations, Arkansas, United States
Unknown Facility
Many Locations, California, United States
Unknown Facility
Many Locations, Colorado, United States
Unknown Facility
Many Locations, Connecticut, United States
Unknown Facility
Many Locations, Delaware, United States
Unknown Facility
Many Locations, Florida, United States
Unknown Facility
Many Locations, Georgia, United States
Unknown Facility
Many Locations, Hawaii, United States
Unknown Facility
Many Locations, Idaho, United States
Unknown Facility
Many Locations, Illinois, United States
Unknown Facility
Many Locations, Indiana, United States
Unknown Facility
Many Locations, Iowa, United States
Unknown Facility
Many Locations, Kansas, United States
Unknown Facility
Many Locations, Kentucky, United States
Unknown Facility
Many Locations, Louisiana, United States
Unknown Facility
Many Locations, Maine, United States
Unknown Facility
Many Locations, Maryland, United States
Unknown Facility
Many Locations, Massachusetts, United States
Unknown Facility
Many Locations, Michigan, United States
Unknown Facility
Many Locations, Minnesota, United States
Unknown Facility
Many Locations, Mississippi, United States
Unknown Facility
Many Locations, Missouri, United States
Unknown Facility
Many Locations, Montana, United States
Unknown Facility
Many Locations, Nebraska, United States
Unknown Facility
Many Locations, Nevada, United States
Unknown Facility
Many Locations, New Hampshire, United States
Unknown Facility
Many Locations, New Jersey, United States
Unknown Facility
Many Locations, New Mexico, United States
Unknown Facility
Many Locations, New York, United States
Unknown Facility
Many Locations, North Carolina, United States
Unknown Facility
Many Locations, North Dakota, United States
Unknown Facility
Many Locations, Ohio, United States
Unknown Facility
Many Locations, Oklahoma, United States
Unknown Facility
Many Locations, Oregon, United States
Unknown Facility
Many Locations, Pennsylvania, United States
Unknown Facility
Many Locations, Rhode Island, United States
Unknown Facility
Many Locations, South Carolina, United States
Unknown Facility
Many Locations, South Dakota, United States
Unknown Facility
Many Locations, Tennessee, United States
Unknown Facility
Many Locations, Texas, United States
Unknown Facility
Many Locations, Utah, United States
Unknown Facility
Many Locations, Vermont, United States
Unknown Facility
Many Locations, Virginia, United States
Unknown Facility
Many Locations, Washington, United States
Unknown Facility
Many Locations, West Virginia, United States
Unknown Facility
Many Locations, Wisconsin, United States
Unknown Facility
Many Locations, Wyoming, United States
Biospecimen
saliva, optional blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 15, 2012
Study Start
March 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 8, 2015
Record last verified: 2015-05