Hepatocellular Carcinoma Registry for Turkey (3K Trial)

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: No Intervention

• Registration Number: NCT01473121
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Study Start: 2012-08-13
• Primary Completion: 2017-06-30
• Study Completion: 2018-07-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	No Intervention	-

Primary Outcome Measures

Name	Time	Method
Descriptive analysis of clinical profile of newly diagnosed HCC patients	Baseline
Descriptive analysis of HCC risk factors	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with underlying liver disease and family history	Baseline
Treatment options as applied by doctors to HCC patients	Up to approximately 5 years
Overall survival time since diagnosis	Up to approximately 5 years
Number of participants with adverse events	Up to approximately 5 years
Descriptive analysis of demographic characteristics of HCC patients	Baseline
Descriptive analysis of clinical characteristics of HCC patients	Up to approximately 5 years
Descriptive analysis of tumor properties	Up to approximately 5 years