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Hepatocellular Carcinoma Registry for Turkey (3K Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473121
First Posted: November 17, 2011
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: Profile of the Hepatocellular Carcinoma Patients in Turkey

Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Number of participants with / without underlying liver disease and family history [ Time Frame: In the first 3 months ]
  • Number of risk factors [ Time Frame: In the first 3 months ]
  • Change in tumor stage during treatment [ Time Frame: Baseline and Every 3 months ]

Enrollment: 600
Actual Study Start Date: August 13, 2012
Estimated Study Completion Date: October 31, 2017
Primary Completion Date: June 30, 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473121


Locations
Turkey
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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 ( Other Identifier: company internal )
First Submitted: November 2, 2011
First Posted: November 17, 2011
Last Update Posted: September 12, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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