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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598597
First Posted: May 15, 2012
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
23andMe, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
May 9, 2012
May 15, 2012
May 8, 2015
March 2012
November 2014   (Final data collection date for primary outcome measure)
Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT01598597 on ClinicalTrials.gov Archive Site
  • Clinical characteristics (current disease status/previous treatments) of subjects participating in this study [ Time Frame: 24 months ]
  • Demographic distribution (age, sex) of subjects participating in this study [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
saliva, optional blood
Probability Sample
Participants with history of metastatic or locally recurrent breast cancer treated with Avastin
  • Breast Cancer
  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Glioblastoma
  • Renal Cell Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
November 2014
November 2014   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01598597
GO28289
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
23andMe, Inc.
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
May 2015