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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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ClinicalTrials.gov Identifier: NCT01598597
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer Colorectal Cancer Non-Small Cell Lung Cancer Glioblastoma Renal Cell Cancer

Study Design

Study Type : Observational
Actual Enrollment : 276 participants
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
Study Start Date : March 2012
Primary Completion Date : November 2014
Study Completion Date : November 2014

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Clinical characteristics (current disease status/previous treatments) of subjects participating in this study [ Time Frame: 24 months ]
  2. Demographic distribution (age, sex) of subjects participating in this study [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
saliva, optional blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598597

  Hide Study Locations
United States, Alabama
Many locations, Alabama, United States
United States, Alaska
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United States, Arizona
Many locations, Arizona, United States
United States, Arkansas
Many locations, Arkansas, United States
United States, California
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United States, Colorado
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United States, Connecticut
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United States, Delaware
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United States, Florida
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United States, Georgia
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United States, Hawaii
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United States, Idaho
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United States, Illinois
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United States, Indiana
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United States, Iowa
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United States, Kansas
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United States, Kentucky
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United States, Louisiana
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United States, Maine
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United States, Maryland
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United States, Massachusetts
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United States, Michigan
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United States, Minnesota
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United States, Mississippi
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United States, Missouri
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United States, Montana
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United States, Nebraska
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United States, Nevada
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United States, New Hampshire
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United States, New Jersey
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United States, New Mexico
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United States, New York
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United States, Washington
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United States, West Virginia
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United States, Wisconsin
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United States, Wyoming
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Sponsors and Collaborators
Genentech, Inc.
23andMe, Inc.
Study Director: Clinical Trials Genentech, Inc.
More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01598597     History of Changes
Other Study ID Numbers: GO28289
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Renal Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type