Hepatocellular Carcinoma Registry for Turkey (3K Trial)

This study is currently recruiting participants.
Verified March 2014 by Bayer
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 2, 2011
Last updated: March 21, 2014
Last verified: March 2014

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.

Condition Intervention
Hepatocellular Carcinoma
Other: No Intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Profile of the Hepatocellular Carcinoma Patients in Turkey

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Duration of treatment for chemotherapy and systemic treatment [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with / without underlying liver disease and family history [ Time Frame: In the first 3 months ] [ Designated as safety issue: No ]
  • Number of risk factors [ Time Frame: In the first 3 months ] [ Designated as safety issue: No ]
  • Change in tumor stage during treatment [ Time Frame: Baseline and Every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Other: No Intervention
All treatment options (inc. surgery, TACE, drugs) will be registered.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that are diagnosed with hepatocellular carcinoma in last 3 months


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473121

Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Many Locations, Turkey
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01473121     History of Changes
Other Study ID Numbers: 15807, NX1110TR
Study First Received: November 2, 2011
Last Updated: March 21, 2014
Health Authority: Turkey: Ministry of Health General Directorate of Pharmaceuticals and Pharmacy

Keywords provided by Bayer:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 15, 2014