Study Completed

Hepatocellular carcinoma

Bayer Identifier:

15807

ClinicalTrials.gov Identifier:

NCT01473121

EudraCT Number:

Not Available

EU CT Number:

Not Available

Hepatocellular carcinoma registry for Turkey (3K Trial)

Trial purpose

This registry study is national, multi-center, prospective study without any interventions to the treatment strategies and/or decisions of the investigators. It is designed in order to determine the general profile of HCC patients in Turkey. Socio-demographic characteristics, family history, medical history and treatment pattern of HCC patients will be evaluated.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Inclusion Criteria
- To be diagnosed with hepatocellular carcinoma in last 3 months
- To be older than 18 years old
- To sign informed consent form (ICF)
Exclusion Criteria
- Patients that does not sign or withdraw informed consent form.
- According to investigator’s opinion; existence of any situation/condition that will significantly complicate patient follow up.
- Currently or previously taking part in 3K observational study

Trial summary

Enrollment Goal

600

Trial Dates

August 2012 - July 2018

Phase

N/A

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Turkey

Primary Outcome

Descriptive analysis of HCC risk factors
i.e. smoking and alcohol consumption status; family history for hepatitis, HCC, and other malignancies; history of hepatic disease and blood transfusion; concomitant diseases; treatments applied
Time Frame:
Baseline
Safety Issue:
Yes
Descriptive analysis of clinical profile of newly diagnosed HCC patients
Time Frame:
Baseline
Safety Issue:
Yes

Secondary Outcome

Number of participants with underlying liver disease and family history
Time Frame:
Baseline
Safety Issue:
No
Treatment options as applied by doctors to HCC patients
Time Frame:
Up to approximately 5 years
Safety Issue:
No
Overall survival time since diagnosis
Time Frame:
Up to approximately 5 years
Number of participants with adverse events
Time Frame:
Up to approximately 5 years
Descriptive analysis of demographic characteristics of HCC patients
Time Frame:
Baseline
Descriptive analysis of clinical characteristics of HCC patients
Time Frame:
Up to approximately 5 years
Descriptive analysis of tumor properties
Time Frame:
Up to approximately 5 years

Trial design

Profile of the Hepatocellular Carcinoma patients in Turkey

Trial Type

Observational

Intervention Type

Other

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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