NCT01473121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

August 13, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

4.9 years

First QC Date

November 2, 2011

Last Update Submit

July 2, 2019

Conditions

Keywords

Hepatocellular carcinomaRegistryTurkey

Outcome Measures

Primary Outcomes (2)

  • Descriptive analysis of HCC risk factors

    i.e. smoking and alcohol consumption status; family history for hepatitis, HCC, and other malignancies; history of hepatic disease and blood transfusion; concomitant diseases; treatments applied

    Baseline

  • Descriptive analysis of clinical profile of newly diagnosed HCC patients

    Baseline

Secondary Outcomes (7)

  • Number of participants with underlying liver disease and family history

    Baseline

  • Treatment options as applied by doctors to HCC patients

    Up to approximately 5 years

  • Overall survival time since diagnosis

    Up to approximately 5 years

  • Number of participants with adverse events

    Up to approximately 5 years

  • Descriptive analysis of demographic characteristics of HCC patients

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Group 1

Other: No Intervention

Interventions

All treatment options (inc. surgery, TACE, drugs) will be registered.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that are diagnosed with hepatocellular carcinoma in last 3 months

You may qualify if:

  • To be diagnosed with hepatocellular carcinoma in last 3 months
  • To be older than 18 years old
  • To sign informed consent form (ICF)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 17, 2011

Study Start

August 13, 2012

Primary Completion

June 30, 2017

Study Completion

July 12, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations