Carcinoma, HepatocellularNCT01191385
GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start
An observational study of Carcinoma, Hepatocellular, run by Bayer at 24 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Any treatment for unresectable HCC as chosen by the physician
- How many people
- 0 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2010to Dec 2013
- 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: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Multiple Locations, Arkansas
Study site
Multiple Locations, California
Study site
Multiple Locations, Colorado
Study site
Multiple Locations, District of Columbia
Study site
Multiple Locations, Florida
Study site
Multiple Locations, Georgia
Study site
Multiple Locations, Illinois
Study site
Multiple Locations, Indiana
Study site
Multiple Locations, Iowa
Study site
Multiple Locations, Kentucky
Study site
Multiple Locations, Louisiana
Study site
Multiple Locations, Maryland
Study site
Multiple Locations, Massachusetts
Study site
Multiple Locations, Michigan
Study site
Multiple Locations, Minnesota
Study site
Multiple Locations, Missouri
Study site
Multiple Locations, New Hampshire
Study site
Multiple Locations, New Jersey
Study site
Multiple Locations, New York
Study site
Multiple Locations, Oregon
Study site
Multiple Locations, Pennsylvania
Study site
Multiple Locations, South Carolina
Study site
Multiple Locations, Texas
Study site
Multiple Locations, Virginia
About this study
Official title: 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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Any treatment for unresectable HCC as chosen by the physician
- Keywords
- HCC, Liver cancer, Cancer of liver, Cancer, liver, Hepatic cancer, Cancer, hepatic, Carcinoma, hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any treatment for unresectable HCC as chosen by the physicianDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Any treatment for unresectable HCC as chosen by the physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: up to 3,3 years
Secondary outcomes (5)
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)
Measured: 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)
Measured: up to 3,3 years
Evaluation of safety and tolerability of treatments that are used for patients with HCC (collection of all adverse events)
Measured: 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
Measured: 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)
Measured: up to 3,3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Study is officially cancelled bevore FPFV.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191385
- Sponsor's protocol ID
- 14611
- Other IDs
- NX0901
- Status last verified
- Mar 2015
- First submitted
- 27 Aug 2010
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01191385
- Acronym / sponsor ID
- 14611
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, Liver cancer, Cancer of liver, Cancer, liver, Hepatic cancer, Cancer, hepatic, Carcinoma, hepatocellular
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study is officially cancelled bevore FPFV.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Any treatment for unresectable HCC as chosen by the physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any treatment for unresectable HCC as chosen by the physicianOnly 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. | Drug | Group 1 |
Primary outcome
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
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Bayer at 24 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 was withdrawn before enrolling participants, so there are no results.
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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.