AzTrials
AzTrials

Breast CancerNCT01598597

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 study of Breast Cancer and Colorectal Cancer, run by Genentech, Inc. at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
276 participants
Where
50 sitesUnited States
Study dates
Mar 2012to Nov 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Study site

    Many Locations, Alabama

  • Study site

    Many Locations, Alaska

  • Study site

    Many Locations, Arizona

  • Study site

    Many Locations, Arkansas

  • Study site

    Many Locations, California

  • Study site

    Many Locations, Colorado

  • Study site

    Many Locations, Connecticut

  • Study site

    Many Locations, Delaware

  • Study site

    Many Locations, Florida

  • Study site

    Many Locations, Georgia

  • Study site

    Many Locations, Hawaii

  • Study site

    Many Locations, Idaho

  • Study site

    Many Locations, Illinois

  • Study site

    Many Locations, Indiana

  • Study site

    Many Locations, Iowa

  • Study site

    Many Locations, Kansas

  • Study site

    Many Locations, Kentucky

  • Study site

    Many Locations, Louisiana

  • Study site

    Many Locations, Maine

  • Study site

    Many Locations, Maryland

  • Study site

    Many Locations, Massachusetts

  • Study site

    Many Locations, Michigan

  • Study site

    Many Locations, Minnesota

  • Study site

    Many Locations, Mississippi

  • Study site

    Many Locations, Missouri

  • Study site

    Many Locations, Montana

  • Study site

    Many Locations, Nebraska

  • Study site

    Many Locations, Nevada

  • Study site

    Many Locations, New Hampshire

  • Study site

    Many Locations, New Jersey

  • Study site

    Many Locations, New Mexico

  • Study site

    Many Locations, New York

  • Study site

    Many Locations, North Carolina

  • Study site

    Many Locations, North Dakota

  • Study site

    Many Locations, Ohio

  • Study site

    Many Locations, Oklahoma

  • Study site

    Many Locations, Oregon

  • Study site

    Many Locations, Pennsylvania

  • Study site

    Many Locations, Rhode Island

  • Study site

    Many Locations, South Carolina

  • Study site

    Many Locations, South Dakota

  • Study site

    Many Locations, Tennessee

  • Study site

    Many Locations, Texas

  • Study site

    Many Locations, Utah

  • Study site

    Many Locations, Vermont

  • Study site

    Many Locations, Virginia

  • Study site

    Many Locations, Washington

  • Study site

    Many Locations, West Virginia

  • Study site

    Many Locations, Wisconsin

  • Study site

    Many Locations, Wyoming

Other trials in United States

About this study

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

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.

Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Glioblastoma, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01598597
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA)

    Measured: 24 months

Secondary outcomes (2)

  1. Clinical characteristics (current disease status/previous treatments) of subjects participating in this study

    Measured: 24 months

  2. Demographic distribution (age, sex) of subjects participating in this study

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01598597
Sponsor's protocol ID
GO28289
Status last verified
May 2015
First submitted
9 May 2012
Last updated
8 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Colorectal Cancer, run by Genentech, Inc. at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects who complete the survey and who provide evaluable genetic information (DNA) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01598597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in