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)

May 7, 2015 updated by: Genentech, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Many locations, Alabama, United States
    • Alaska
      • Many locations, Alaska, United States
    • Arizona
      • Many locations, Arizona, United States
    • Arkansas
      • Many locations, Arkansas, United States
    • California
      • Many locations, California, United States
    • Colorado
      • Many locations, Colorado, United States
    • Connecticut
      • Many locations, Connecticut, United States
    • Delaware
      • Many locations, Delaware, United States
    • Florida
      • Many locations, Florida, United States
    • Georgia
      • Many locations, Georgia, United States
    • Hawaii
      • Many locations, Hawaii, United States
    • Idaho
      • Many locations, Idaho, United States
    • Illinois
      • Many locations, Illinois, United States
    • Indiana
      • Many locations, Indiana, United States
    • Iowa
      • Many locations, Iowa, United States
    • Kansas
      • Many locations, Kansas, United States
    • Kentucky
      • Many locations, Kentucky, United States
    • Louisiana
      • Many locations, Louisiana, United States
    • Maine
      • Many locations, Maine, United States
    • Maryland
      • Many locations, Maryland, United States
    • Massachusetts
      • Many locations, Massachusetts, United States
    • Michigan
      • Many locations, Michigan, United States
    • Minnesota
      • Many locations, Minnesota, United States
    • Mississippi
      • Many locations, Mississippi, United States
    • Missouri
      • Many locations, Missouri, United States
    • Montana
      • Many locations, Montana, United States
    • Nebraska
      • Many locations, Nebraska, United States
    • Nevada
      • Many locations, Nevada, United States
    • New Hampshire
      • Many locations, New Hampshire, United States
    • New Jersey
      • Many locations, New Jersey, United States
    • New Mexico
      • Many locations, New Mexico, United States
    • New York
      • Many locations, New York, United States
    • North Carolina
      • Many locations, North Carolina, United States
    • North Dakota
      • Many locations, North Dakota, United States
    • Ohio
      • Many locations, Ohio, United States
    • Oklahoma
      • Many locations, Oklahoma, United States
    • Oregon
      • Many locations, Oregon, United States
    • Pennsylvania
      • Many locations, Pennsylvania, United States
    • Rhode Island
      • Many locations, Rhode Island, United States
    • South Carolina
      • Many locations, South Carolina, United States
    • South Dakota
      • Many locations, South Dakota, United States
    • Tennessee
      • Many locations, Tennessee, United States
    • Texas
      • Many locations, Texas, United States
    • Utah
      • Many locations, Utah, United States
    • Vermont
      • Many locations, Vermont, United States
    • Virginia
      • Many locations, Virginia, United States
    • Washington
      • Many locations, Washington, United States
    • West Virginia
      • Many locations, West Virginia, United States
    • Wisconsin
      • Many locations, Wisconsin, United States
    • Wyoming
      • Many locations, Wyoming, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical characteristics (current disease status/previous treatments) of subjects participating in this study
Time Frame: 24 months
24 months
Demographic distribution (age, sex) of subjects participating in this study
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

23andMe, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO28289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe