Hepatocellular Carcinoma Registry for Turkey (3K Trial)

Hepatocellular Carcinoma Clinical Trial

Official title:

Profile of the Hepatocellular Carcinoma Patients in Turkey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473121
• Other study ID #: 15807
• Secondary ID: NX1110TR
• Status: Completed
• Start date: August 13, 2012
• Est. completion date: July 12, 2018

Study information

• Verified date: July 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 12, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• No Intervention
All treatment options (inc. surgery, TACE, drugs) will be registered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	Descriptive analysis of clinical profile of newly diagnosed HCC patients		Baseline
Secondary	Number of participants with underlying liver disease and family history		Baseline
Secondary	Treatment options as applied by doctors to HCC patients		Up to approximately 5 years
Secondary	Overall survival time since diagnosis		Up to approximately 5 years
Secondary	Number of participants with adverse events		Up to approximately 5 years
Secondary	Descriptive analysis of demographic characteristics of HCC patients		Baseline
Secondary	Descriptive analysis of clinical characteristics of HCC patients		Up to approximately 5 years
Secondary	Descriptive analysis of tumor properties		Up to approximately 5 years

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