Clinical trial NCT01598597: 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: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Non-Small Cell Lung Cancer
Glioblastoma
Renal Cell Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: 23andMe, Inc.
First posted: 2012-05-15
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with history of metastatic or locally recurrent breast 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)
timeFrame: 24 months
Secondary outcomes:
measure: Clinical characteristics (current disease status/previous treatments) of subjects participating in this study
timeFrame: 24 months
measure: Demographic distribution (age, sex) of subjects participating in this study
timeFrame: 24 months
Other outcomes:
Locations:
city: Many locations
country: United States
state: Alabama
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state: Alaska
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state: Arkansas
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state: California
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state: Colorado
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state: Connecticut
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state: Florida
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state: Georgia
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state: Hawaii
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state: Idaho
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state: Illinois
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state: Indiana
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state: Kansas
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state: Kentucky
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state: Louisiana
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state: Maine
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state: Maryland
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state: Michigan
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state: Minnesota
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state: Mississippi
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state: Missouri
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state: Montana
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state: Nebraska
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state: Nevada
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state: New Hampshire
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state: New Jersey
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state: New Mexico
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state: New York
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state: Ohio
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state: Rhode Island
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state: South Carolina
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state: South Dakota
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state: Tennessee
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state: Texas
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state: Utah
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state: Vermont
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state: Virginia
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state: Washington
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country: United States
state: West Virginia
city: Many locations
country: United States
state: Wisconsin
city: Many locations
country: United States
state: Wyoming
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: