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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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 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.
| Condition |
|---|
|
Breast Cancer Colorectal Cancer Non-Small Cell Lung Cancer Glioblastoma Renal Cell Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
- 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 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
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: | January 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Colorectal Neoplasms Glioblastoma Lung Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013