Multiple Locations, Turkey (Türkiye)
NCT Number: NCT01473121
Hepatocellular Carcinoma Registry for Turkey (3K Trial)
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
No intervention
OtherAll treatment options (inc. surgery, TACE, drugs) will be registered.
Primary outcomes
-
Descriptive analysis of HCC risk factors
Time frame: 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
-
Descriptive analysis of clinical profile of newly diagnosed HCC patients
Time frame: Baseline
Secondary outcomes
-
Number of participants with underlying liver disease and family history
Time frame: Baseline
-
Treatment options as applied by doctors to HCC patients
Time frame: Up to approximately 5 years
-
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
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study title
Profile of the Hepatocellular Carcinoma Patients in Turkey
Important dates
- Study start
- 2012
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Nov 17, 2011
- Registry last updated
- Jul 5, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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