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 is currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Collaborator:
23andMe, Inc.
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01598597
First received: May 9, 2012
Last updated: January 18, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants with history of metastatic or locally recurrent breast cancer treated with Avastin

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598597

Contacts
Contact: Please reference Study ID Number: GO28289 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Many locations, Alabama, United States
United States, Alaska
Recruiting
Many locations, Alaska, United States
United States, Arizona
Recruiting
Many locations, Arizona, United States
United States, Arkansas
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Many locations, Arkansas, United States
United States, California
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Many locations, California, United States
United States, Colorado
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Many locations, Colorado, United States
United States, Connecticut
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Many locations, Connecticut, United States
United States, Delaware
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Many locations, Delaware, United States
United States, Florida
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Many locations, Florida, United States
United States, Georgia
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Many locations, Georgia, United States
United States, Hawaii
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Many locations, Hawaii, United States
United States, Idaho
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Many locations, Idaho, United States
United States, Illinois
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Many locations, Illinois, United States
United States, Indiana
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Many locations, Indiana, United States
United States, Iowa
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Many locations, Iowa, United States
United States, Kansas
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Many locations, Kansas, United States
United States, Kentucky
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Many locations, Kentucky, United States
United States, Louisiana
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Many locations, Louisiana, United States
United States, Maine
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Many locations, Maine, United States
United States, Maryland
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Many locations, Maryland, United States
United States, Massachusetts
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Many locations, Massachusetts, United States
United States, Michigan
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Many locations, Michigan, United States
United States, Minnesota
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Many locations, Minnesota, United States
United States, Mississippi
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Many locations, Mississippi, United States
United States, Missouri
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Many locations, Missouri, United States
United States, Montana
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Many locations, Montana, United States
United States, Nebraska
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Many locations, Nebraska, United States
United States, Nevada
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Many locations, Nevada, United States
United States, New Hampshire
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Many locations, New Hampshire, United States
United States, New Jersey
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Many locations, New Jersey, United States
United States, New Mexico
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Many locations, New Mexico, United States
United States, New York
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Many locations, New York, United States
United States, North Carolina
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Many locations, North Carolina, United States
United States, North Dakota
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Many locations, North Dakota, United States
United States, Ohio
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Many locations, Ohio, United States
United States, Oklahoma
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Many locations, Oklahoma, United States
United States, Oregon
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Many locations, Oregon, United States
United States, Pennsylvania
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Many locations, Pennsylvania, United States
United States, Rhode Island
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Many locations, Rhode Island, United States
United States, South Carolina
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Many locations, South Carolina, United States
United States, South Dakota
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Many locations, South Dakota, United States
United States, Tennessee
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Many locations, Tennessee, United States
United States, Texas
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Many locations, Texas, United States
United States, Utah
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Many locations, Utah, United States
United States, Vermont
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Many locations, Vermont, United States
United States, Virginia
Recruiting
Many locations, Virginia, United States
United States, Washington
Recruiting
Many locations, Washington, United States
United States, West Virginia
Recruiting
Many locations, West Virginia, United States
United States, Wisconsin
Recruiting
Many locations, Wisconsin, United States
United States, Wyoming
Recruiting
Many locations, Wyoming, United States
Sponsors and Collaborators
Genentech
23andMe, Inc.
Investigators
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 23, 2013