Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib (GIDEON)

October 14, 2016 updated by: Bayer
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3371

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

  • Canada
      • Many Locations, Canada
  • China
      • Many Locations, China
  • Colombia
      • Many Locations, Colombia
  • Croatia
      • Many Locations, Croatia
  • Czech Republic
      • Many Locations, Czech Republic
  • Finland
      • Many Locations, Finland
  • France
      • Many Locations, France
  • Greece
      • Many Locations, Greece
  • Hong Kong
      • Many Locations, Hong Kong
  • Hungary
      • Many Locations, Hungary
  • India
      • Many Locations, India
  • Indonesia
      • Many Locations, Indonesia
  • Israel
      • Many Locations, Israel
  • Italy
      • Many Locations, Italy
  • Japan
      • Many Locations, Japan
  • Kazakhstan
      • Many Locations, Kazakhstan
  • Korea, Republic of
      • Many Locations, Korea, Republic of
  • Libyan Arab Jamahiriya
      • Many Locations, Libyan Arab Jamahiriya
  • Malaysia
      • Many Locations, Malaysia
  • Mexico
      • Many Locations, Mexico
  • Norway
      • Many Locations, Norway
  • Pakistan
      • Many Locations, Pakistan
  • Philippines
      • Many Locations, Philippines
  • Portugal
      • Many Locations, Portugal
  • Qatar
      • Many Locations, Qatar
  • Romania
      • Many Locations, Romania
  • Russian Federation
      • Many Locations, Russian Federation
  • Singapore
      • Many Locations, Singapore
  • Slovakia
      • Many Locations, Slovakia
  • Spain
      • Many Locations, Spain
  • Sweden
      • Many Locations, Sweden
  • Syrian Arab Republic
      • Many Locations, Syrian Arab Republic
  • Thailand
      • Many Locations, Thailand
  • Ukraine
      • Many Locations, Ukraine
  • United Arab Emirates
      • Many Locations, United Arab Emirates
  • United States
    • Alabama
      • Many Locations, Alabama, 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
    • Florida
      • Many Locations, Florida, United States
    • Georgia
      • Many Locations, Georgia, United States
    • Hawaii
      • Many Locations, Hawaii, 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
    • Maryland
      • Many Locations, Maryland, United States
    • Massachusetts
      • Many Locations, Massachusetts, United States
    • Michigan
      • Many Locations, Michigan, United States
    • Minnesota
      • Many Locations, Minnesota, United States
    • Missouri
      • Many Locations, Missouri, 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 York
      • Many Locations, New York, United States
    • North Carolina
      • Many Locations, North Carolina, 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
    • South Carolina
      • Many Locations, South Carolina, United States
    • Tennessee
      • Many Locations, Tennessee, United States
    • Texas
      • Many Locations, Texas, United States
    • Utah
      • Many Locations, Utah, United States
    • Virginia
      • Many Locations, Virginia, United States
    • Washington
      • Many Locations, Washington, United States
    • Wisconsin
      • Many Locations, Wisconsin, United States
  • Uruguay
      • Many Locations, Uruguay
  • Venezuela
      • Many Locations, Venezuela
  • Vietnam
      • Many Locations, Vietnam

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

Non-Probability Sample

Study Population

Patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions and in a variety of patient subsets.

Description

Inclusion Criteria:

  • Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
  • Patients must have signed an informed consent form
  • Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

  • Exclusion criteria must follow the approved local product information

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
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions
Time Frame: at each follow-up visit, every 2-4 months on average
at each follow-up visit, every 2-4 months on average

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months
The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months
To evaluate the methods of patient evaluation, diagnosis and follow up
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months
To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months
To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months
Reports of adverse events
Time Frame: at every visit, roughly every 2-4 months
at every visit, roughly every 2-4 months

Collaborators and Investigators

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

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (ESTIMATE)

December 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13414
  • NX0802 (OTHER: company internal)

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.

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