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Completed

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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Key information

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

Other

All treatment options (inc. surgery, TACE, drugs) will be registered.

Primary outcomes

  1. 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

  2. Descriptive analysis of clinical profile of newly diagnosed HCC patients

    Time frame: Baseline

Secondary outcomes

  1. Number of participants with underlying liver disease and family history

    Time frame: Baseline

  2. Treatment options as applied by doctors to HCC patients

    Time frame: Up to approximately 5 years

  3. Overall survival time since diagnosis

    Time frame: Up to approximately 5 years

  4. Number of participants with adverse events

    Time frame: Up to approximately 5 years

  5. Descriptive analysis of demographic characteristics of HCC patients

    Time frame: Baseline

  6. Descriptive analysis of clinical characteristics of HCC patients

    Time frame: Up to approximately 5 years

  7. 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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