check_circleStudy 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
  • - To be diagnosed with hepatocellular carcinoma in last 3 months
    - To be older than 18 years old
    - To sign informed consent form (ICF)

  • - 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
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes
  • Descriptive analysis of clinical profile of newly diagnosed HCC patients
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

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