Trial document





This trial has been registered retrospectively.
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  DRKS00019035

Trial Description

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Title

LOGGIC Core BioClinical Data Bank

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Trial Acronym

LOGGIC Core

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URL of the Trial

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Brief Summary in Lay Language

Establishment of a molecular and clinical database for pediatric low-grade gliomas. The data will be used to improve the understanding of the tumor biology of the disease. For this purpose, state-of-the-art techniques are used to obtain a "fingerprint" of each individual tumor.

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Brief Summary in Scientific Language

The overall aim of the LOGGIC Core BioClinical Data Bank (LOGGIC Core) is to set up a molecular and clinical data bank for pediatric low grade gliomas (LGG). The data will be used to enhance the understanding of tumorbiology of the disease but also to correlate molecular subgroups of LGG with clinical outcome. In addition, the registry will serve as a data bank for providing molecular data for other trials of the LOGGIC program. Tumor samples will be collected as part of the routine standard of care clinical management of LGG patients. The registry is a non-interventional collection of molecular and clinical data. State-of-the-art molecular profiling technologies will be applied to get a “fingerprint” of each individual tumour. The treating physicians will have access to the molecular information/targets of their patients and carry the full responsibility as to whether and in which way they use these data for clinical use. LOGGIC Core will collect clinical and histological baseline data and provide molecular genetic data to other trials of the LOGGIC program including the LOGGIC Europe and other clinical trials. As such, LOGGIC Core is an integral and essential part of the wider LOGGIC concept.
Any patient with newly diagnosed LGG either by histology and/or imaging will be registered into LOGGIC Core after informed consent. With registration in LOGGIC Core, formalin-fixed paraffin-embedded (FFPE) and fresh-frozen tissue and blood need to be submitted for molecular diagnostics .

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019035
  •   2019/11/29
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  •   yes
  •   Approved
  •   S-064/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   Low Grade Glioma
  •   D33 -  Benign neoplasm of brain and other parts of central nervous system
  •   D43 -  Neoplasm of uncertain or unknown behaviour of brain and central nervous system
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Interventions/Observational Groups

  •   From samples taken during the routine (tumor tissue and blood), a molecular fingerprint of the tumor is generated by DNA methylation profile and RNA sequencing. Using this data, it is possible for the attending physician at the participating center to select potential AMG studies for the patient as an additional option to standard of care therapy. However, LOGGIC Core does not provide therapy advice, but is a purely scientific approach.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Establishment of a molecular and clinical data base for pediatric low grade glioma

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Secondary Outcome

To collect molecular tumour characteristics of LGG patients for exploratory analysis of biomarker and clinical outcome.

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Netherlands
  •   Austria
  •   Norway
  •   Australia
  •   Belgium
  •   Denmark
  •   Finland
  •   Greece
  •   United Kingdom
  •   Ireland
  •   Italy
  •   Sweden
  •   Hungary
  •   Spain
  •   Czech Republic
  •   Portugal
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2019/04/05
  •   5000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   20   Years
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Additional Inclusion Criteria

- Age < 21 years.

- Histologically verified LGG
Exceptions (i.e. MRI based diagnosis) can be accepted only where a biopsy would pose an unacceptable risk to damage of eloquent brain structures.

- Primary diagnosis or progression following initial observation.

- Fresh frozen and paraffin tumour material together with blood available for molecular diagnostics.
In the case the date of diagnosis is earlier as the start of LOGGIC Core in a country, submission of fresh frozen and paraffin tumour material together with blood is mandatory with no exceptions (in other words, one can include “retrospective cases” only if material is available).

- Before patient registration, written informed consent, including data and tumour material transfer, must be given according to ICH/GCP, and national/local regulations.

- No previous treatment (except surgery)

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Exclusion Criteria

any previous treatment with chemo/radio therapy, excluding surgery

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Addresses

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    • Hopp Kindertumorzentrum Heidelberg
    • Mr.  Prof. Dr.  Olaf  Witt 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Hopp Kindertumorzentrum Heidelberg (KiTZ)
    • Mr.  Prof. Dr.  Olaf  Witt 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Hopp Kindertumorzentrum Heidelberg
    • Ms.  Dr.  Claudia  Caspar 
    • Im Neuenheimer Feld 130.3
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • The Brain Tumour CharityHartshead House
    • Mr.  Dr.  David  Jenkinson 
    • 61-65 Victoria Road
    • GU14 7PA  Hampshire
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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