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Hepatocellular Carcinoma Registry for Turkey (3K Trial)

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ClinicalTrials.gov Identifier: NCT01473121
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Hepatocellular Carcinoma Other: No Intervention

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Profile of the Hepatocellular Carcinoma Patients in Turkey
Actual Study Start Date : August 13, 2012
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : May 31, 2018

Group/Cohort Intervention/treatment
Group 1 Other: No Intervention
All treatment options (inc. surgery, TACE, drugs) will be registered.



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

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


Information from the National Library of Medicine

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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

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
Multiple Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01473121     History of Changes
Other Study ID Numbers: 15807
NX1110TR ( Other Identifier: company internal )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

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