Hepatocellular CarcinomaNCT01473121
Hepatocellular Carcinoma Registry for Turkey (3K Trial)
An observational study of Hepatocellular Carcinoma, run by Bayer at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2012to 12 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are diagnosed with hepatocellular carcinoma in last 3 months
Who may be able to join
- To be diagnosed with hepatocellular carcinoma in last 3 months
- To be older than 18 years old
- To sign informed consent form (ICF)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Profile of the Hepatocellular Carcinoma Patients in Turkey
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- No Intervention
- Keywords
- Hepatocellular carcinoma, Registry, Turkey
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
All treatment options (inc. surgery, TACE, drugs) will be registered.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Descriptive analysis of clinical profile of newly diagnosed HCC patients
Measured: Baseline
Secondary outcomes (7)
Number of participants with underlying liver disease and family history
Measured: Baseline
Treatment options as applied by doctors to HCC patients
Measured: Up to approximately 5 years
Overall survival time since diagnosis
Measured: Up to approximately 5 years
Number of participants with adverse events
Measured: Up to approximately 5 years
Descriptive analysis of demographic characteristics of HCC patients
Measured: Baseline
Descriptive analysis of clinical characteristics of HCC patients
Measured: Up to approximately 5 years
Descriptive analysis of tumor properties
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study start13 Aug 2012
- Primary completion30 Jun 2017
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473121
- Sponsor's protocol ID
- 15807
- Other IDs
- NX1110TR
- Status last verified
- Jul 2019
- First submitted
- 2 Nov 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of the Hepatocellular Carcinoma Patients in Turkey
- ClinicalTrials.gov ID
- NCT01473121
- Acronym / sponsor ID
- 15807
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Registry, Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are diagnosed with hepatocellular carcinoma in last 3 months
Key inclusion criteria (3 listed)
- To be diagnosed with hepatocellular carcinoma in last 3 months
- To be older than 18 years old
- To sign informed consent form (ICF)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionAll treatment options (inc. surgery, TACE, drugs) will be registered. | Other | Group 1 |
Primary outcome
Descriptive analysis of HCC risk factors
Time frame: Baseline
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
Descriptive analysis of clinical profile of newly diagnosed HCC patients
Time frame: Baseline
7 secondary outcomes
Number of participants with underlying liver disease and family history
Time frame: Baseline
Treatment options as applied by doctors to HCC patients
Time frame: Up to approximately 5 years
Overall survival time since diagnosis
Time frame: Up to approximately 5 years
Number of participants with adverse events
Time frame: Up to approximately 5 years
Descriptive analysis of demographic characteristics of HCC patients
Time frame: Baseline
Descriptive analysis of clinical characteristics of HCC patients
Time frame: Up to approximately 5 years
Descriptive analysis of tumor properties
Time frame: Up to approximately 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Bayer at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of HCC risk factors (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.