Hepatocellular Carcinoma Registry for Turkey (3K Trial)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 2, 2011
Last updated: February 23, 2016
Last verified: February 2016
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 ]

Enrollment: 600
Study Start Date: August 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01473121     History of Changes
Other Study ID Numbers: 15807  NX1110TR 
Study First Received: November 2, 2011
Last Updated: February 23, 2016
Health Authority: Turkey: Ministry of Health General Directorate of Pharmaceuticals and Pharmacy

Keywords provided by Bayer:
Hepatocellular carcinoma

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

ClinicalTrials.gov processed this record on May 22, 2016