An Observational Pilot Study Evaluating The Feasibility of Conducting Genomewide Association Studies Utilizing Subject-Provided Information in Subjects With Metastatic Breast Cancer Treated With Avastin (Bevacizumab) (InVite)
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Purpose
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 or metastatic breast cancer in the United States who have been previously treated with Avastin (bevacizumab) in combination with chemotherapy between 1 January 2010 and 31 December 2011 prior to study enrollment, or who are currently being treated with Avastin. Participants will be self-referred to this study through the following website: www.23andme.com/invite-study/. They will be recruited online via a number of sources. 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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Observational Pilot Study Evaluating the Feasibility of Conducting Genomewide Association Studies Utilizing Subject-Provided Information in Subjects With Metastatic Breast Cancer Treated With Avastin |
- Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Clinical characteristics (current disease status/previous treatments) of subjects participating in this study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Demographic distribution (age, sex) of subjects participating in this study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
saliva, optional blood
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Participants with history of metastatic or locally recurrent breast cancer treated with Avastin
Inclusion Criteria:
- Locally recurrent breast cancer or MBC, treated or on treatment with bevacizumab, which started prior or up to 31 December 2011
- 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
Exclusion Criteria:
N/A
Contacts and Locations| Contact: Please reference Study ID Number: GO28289 | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 50 Study Locations| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01598597 History of Changes |
| Other Study ID Numbers: | GO28289 |
| Study First Received: | May 9, 2012 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
