Hepatocellular Carcinoma Registry for Turkey (3K Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01473121
First received: November 2, 2011
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.

  Eligibility

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

Criteria

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

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

Locations
Turkey
Recruiting
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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: July 29, 2014
Health Authority: Turkey: Ministry of Health General Directorate of Pharmaceuticals and Pharmacy

Keywords provided by Bayer:
Hepatocellular carcinoma
Registry
Turkey

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

ClinicalTrials.gov processed this record on August 01, 2014