GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start

August 14, 2017 updated by: Bayer

Non Interventional Study in Patients With Diagnosis of HCC in Whom a Decision to Treat With Sorafenib Has Not Been Made at Time of Study Enrollment

This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
    • Arkansas
      • Multiple Locations, Arkansas, United States
    • California
      • Multiple Locations, California, United States
    • Colorado
      • Multiple Locations, Colorado, United States
    • District of Columbia
      • Multiple Locations, District of Columbia, United States
    • Florida
      • Multiple Locations, Florida, United States
    • Georgia
      • Multiple Locations, Georgia, United States
    • Illinois
      • Multiple Locations, Illinois, United States
    • Indiana
      • Multiple Locations, Indiana, United States
    • Iowa
      • Multiple Locations, Iowa, United States
    • Kentucky
      • Multiple Locations, Kentucky, United States
    • Louisiana
      • Multiple Locations, Louisiana, United States
    • Maryland
      • Multiple Locations, Maryland, United States
    • Massachusetts
      • Multiple Locations, Massachusetts, United States
    • Michigan
      • Multiple Locations, Michigan, United States
    • Minnesota
      • Multiple Locations, Minnesota, United States
    • Missouri
      • Multiple Locations, Missouri, United States
    • New Hampshire
      • Multiple Locations, New Hampshire, United States
    • New Jersey
      • Multiple Locations, New Jersey, United States
    • New York
      • Multiple Locations, New York, United States
    • Oregon
      • Multiple Locations, Oregon, United States
    • Pennsylvania
      • Multiple Locations, Pennsylvania, United States
    • South Carolina
      • Multiple Locations, South Carolina, United States
    • Texas
      • Multiple Locations, Texas, United States
    • Virginia
      • Multiple Locations, Virginia, 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

Non-Probability Sample

Study Population

Patients with unresectable HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment and who were never treated with sorafenib in the past

Description

Inclusion Criteria:

  • Outpatients with histologically/cytologically documented or radiographically diagnosed HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis 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:

  • Patients in whom a decision to treat with sorafenib is made at time of study start
  • Patients who have received sorafenib in the past or are currently treated with sorafenib
  • Hospice patients

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Any treatment for unresectable HCC as chosen by the physician
Only those patient are allowed to be enrolled that receive any HCC treatment for unresectable HCC as chosen by the physician except sorafenib. During the course of the study, each treatment is allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of 'real-life' practice patterns of physicians involved in the care of patients with HCC (collection of data on treatments prescribed as well as demographic data and data on the entire medical history)
Time Frame: up to 3,3 years
up to 3,3 years
Evaluation of patient demographics, disease characteristics, methods of patient evaluation, diagnosis and follow-up of patients with HCC, regionally and globally (collection of data on demographics, medical history, diagnostic measurements, follow-up)
Time Frame: up to 3,3 years
up to 3,3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of natural course and outcomes of patients with HCC (collection of data of disease status during the course of the study and the outcome of treatment)
Time Frame: up to 3,3 years
up to 3,3 years
Evaluation of treatment modalities that are used for patients with HCC during the course of their disease (collection of data of all treatments prescribed during the course of the study)
Time Frame: up to 3,3 years
up to 3,3 years
Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)
Time Frame: up to 3,3 years
up to 3,3 years
Evaluation efficacy parameters including: overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR) and stable disease (SD) rate of the various interventions employed in the care of patients with HCC
Time Frame: up to 3,3 years
up to 3,3 years
To evaluate the comorbidities in patients with HCC and their influence on treatment options and outcome (collection of data on concomitant diseases)
Time Frame: up to 3,3 years
up to 3,3 years

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Amgen

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

November 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14611
  • NX0901

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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