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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Systemic oral therapy according to product information

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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