Trial document




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  DRKS00019901

Trial Description

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Title

Study to compile a register of the Liver Cancer Center Heidelberg (LCCH-Register).

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Trial Acronym

LCCH-Register

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/interdisziplinaere-zentren/liver-cancer-center-heidelberg/forschung/forschungsschwerpunkte

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Brief Summary in Lay Language

The LCCH register is a common database that collects and combines the domain knowledge available at the Liver Cancer Center Heidelberg (LCCH), e.g. in the fields of surgery, gastroenterology / hepatology, medical oncology, pathology, radiology, and radiotherapy. This allows the interdisciplinary exchange of information and the optimal use of our knowledge to improve the diagnosis and treatment of patients at the LCCH.

Health information of all patients diagnosed with liver cancer (hepatocellular carcinoma) or bile duct cancer (cholangiocarcinoma), who receive treatment at the Liver Cancer Center Heidelberg, is systematically recorded in the LCCH-Register. This includes clinically relevant data on the respective diagnosis, the therapeutic measures carried out and the post-therapeutic course of the disease. Thus, the LCCH-Register provides the necessary data basis for the continuous improvement of our patient care.

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Brief Summary in Scientific Language

At the Liver Cancer Center Heidelberg (LCCH), patients with primary tumors of the hepatobiliary system are diagnosed and treated based on interdisciplinary tumor board decisions. This involves diagnostics that lie beyond the minimum requirement defined in clinical guidelines and offers a wide range of treatment options that go far beyond the repertoire of a certified liver tumor center.
Through this comprehensive concept, patients with hepatobiliary tumors can be treated interdisciplinary, patient-oriented and individually over the entire course of their disease while the course of the disease is being documented.
The collection and processing of health data is not only a prerequisite for medical care, but also for far-reaching patient management. The required data are to a large extent electronically recorded in a wide range of application systems in predominantly different formats. An exchange and comparison between these systems is not systematically established, resulting in redundancies and inconsistencies which may impact data quality. This kind of unstructured data is difficult to use for interdisciplinary evaluations.
To optimize care and therapy of hepatocellular carcinoma and cholangiocarcinoma in compliance with current treatment recommendations, all patients with primary malignancies of the hepatobiliary system, who are treated at the affiliated clinics / departments of the Liver Cancer Center Heidelberg, should be recorded in the retrospective and prospective LCCH-Register.
This way, the course of the disease and therapy, medical and scientific findings, possible side effects, and the clinical success of the treatment will be documented in a standardized manner. By analyzing better structured and standardized data, optimization potentials can be evaluated. In addition, patient care can be improved in the long term by more efficient interdisciplinary information flow, e.g. through the development of assistance systems.
The applicable data protection regulations are observed. Disadvantages for the general public or the relatives of the patients are not expected.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data sharing of patient-related information is only planned between the departments of the Heidelberg Liver Cancer Center (LCCH) to support the patient care process and research to improve patient outcomes.
For research purposes, only anonymous data will be provided upon application and review of research proposals by the LCCH Advisory Board ("LCCH Beirat").

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Organizational Data

  •   DRKS00019901
  •   2020/01/03
  •   [---]*
  •   yes
  •   Approved
  •   S-693/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1243-6734 
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Health Condition or Problem studied

  •   C23 -  Malignant neoplasm of gallbladder
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C24 -  Malignant neoplasm of other and unspecified parts of biliary tract
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Interventions/Observational Groups

  •   The LCCH register is a common database that collects and combines the domain knowledge available at the Liver Cancer Center Heidelberg (LCCH), e.g. in the fields of surgery, gastroenterology / hepatology, medical oncology, pathology, radiology, and radiotherapy. This allows the interdisciplinary exchange of information and the optimal use of our knowledge to improve the diagnosis and treatment of patients at the LCCH.

    Health information of all patients diagnosed with liver cancer (hepatocellular carcinoma) or bile duct cancer (cholangiocarcinoma), who receive treatment at the Liver Cancer Center Heidelberg, is systematically recorded in the LCCH-Register. This includes clinically relevant data on the respective diagnosis, the therapeutic measures carried out and the post-therapeutic course of the disease. Thus, the LCCH-Register provides the necessary data basis for the continuous improvement of our patient care.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of the project is the creation of a patient registry (i.e. LCCH-Register) for standardized reporting and systematic long-term data collection (retrospective and prospective) of patients with tumors of the hepatobiliary system. The LCCH-Register will help physicians to identify patients who can participate in clinical trials and to record and evaluate clinical, pathological, and molecular parameters of tumors of the hepatobiliary system. This more efficient interdisciplinary information flow will help to improve patient care in the long term.

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Secondary Outcome

(1) Determination of an extended standard dataset for patients with tumors of the hepatobiliary system
(2) Provide a structured documentation method for medical findings
(3) Structuring and collection of retrospective and prospective care data from patients with tumors of the hepatobiliary system in one registry
(4) Make the collected care data available for long-term research / development of new research questions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/07
  •   5000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1) Tumor of the hepatobiliary system
2) Ability to consent
3) Patient information and written consent

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Exclusion Criteria

1) Inability to consent
2) Revocation of consent

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 224
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Ms.  Dr.   Aurelie  Tomczak 
    • Im Neuenheimer Feld 224
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Prof.  Christoph  Springfeld 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 224
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.