German HIT-LOGGIC-Registry, Prospective multicenter registry for children and adolescents with low-grade glioma
Organizational Data
- DRKS-ID:
- DRKS00017089
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-05-19
- Last update in DRKS:
- 2020-12-08
- Registration type:
- Retrospective
Acronym/abbreviation of the study
German HIT-LOGGIC-Registry
URL of the study
No Entry
Brief summary in lay language
Prospective collection of clinical data and their combination with biological and molecular data (LOGGIC Core) of pediatric patients with LGG. Therapeutic interventions are not planned and in case of indication are carried out within separate clinical trials and/or along the recommendations of the SIOP-E working group for LGG in children and adolescents
Brief summary in scientific language
The HIT-LOGGIC registry is a prospective population-based continuation of the previous studies on low-grade gliomas during childhood and adolescence (LGG). The aims are to collect and document clinical data of all respective patients in Germany. These go along with referencing of all diagnostic and therapeutic steps, the registration of sequelae during surveillance as well as the registration of molecular biological data of the tumour and tumour predisposition. Almost all LGG harbour a canonical activation of the MAPK signalling pathway that are due to different mutations. Ten years after diagnosis overall survival is relatively high with 90-95%. Still, a substantial number of patients suffers from chronic disease necessitating multiple therapeutic interventions, that increase therapy and tumour associated morbidity. The main question is which patient, under which circumstances, at which point in time needs treatment at all. For this purpose, clinical and molecular biological data from the LOGGIC Core BioClinical Databank are analysed and continuously evaluated using the multi-state model, which takes into account multiple disease stages. The aims are the improvement of overall survival together with quality of survival. For the first time radiotherapy is avoided regardless of age. In case of indication for non-surgical treatment, early referral of patients to randomized first and second line therapies based on molecular information shall reduce neurotoxicity. The LOGGIC registry cooperates with the pediatric neurosurgical reference panel in order to standardize the neurosurgical care of patients throughout Germany. As a novel approach, epilepsy in the context of LGG disease will be recorded separately with the aim of improving the course of this essential disease complication.
Health condition or problem studied
- ICD10:
- D33.0 - Brain, supratentorial
- ICD10:
- C71.0 - Cerebrum, except lobes and ventricles
- ICD10:
- C72.0 - Spinal cord
- ICD10:
- D33.1 - Brain, infratentorial
- ICD10:
- D33.2 - Brain, unspecified
- ICD10:
- D33.3 - Cranial nerves
- ICD10:
- D33.4 - Spinal cord
- ICD10:
- D33.7 - Other specified parts of central nervous system
- ICD10:
- D33.9 - Central nervous system, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Cliinical patient data are recorded. These will be linked with biological and molecular data of the tumors from the LOGGIC Bioclinical Databank
Endpoints
- Primary outcome:
- The registry study does not have a conventional endpoint. The aim of the study is the registration of the natural disease course of low-grade glioma in childhood and adolescence
- Secondary outcome:
- Epilepsy free survival, molecular and biological data, Tumor predisposition, Quality of survival
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Charité-Universitätsmedizin Berlin Berlin
- Medical center Vestische Kinder- u. Jugendklinik Datteln Datteln
- University medical center Universitätsmedizin Greifswald Greifswald
- University medical center Charité-Universitätsmedizin Berlin Berlin
- Medical center Vestische Kinder- u. Jugendklinik Datteln Datteln
- University medical center Universitätsmedizin Greifswald Greifswald
- University medical center Universitätsklinikum Würzburg Würzburg
- University medical center Universitätsklinikum Regensburg Regensburg
- University medical center Universitätsklinikum Magdeburg Magdeburg
- Medical center Asklepios Klinik Sankt Augustin GmbH St. Augustin
- University medical center Universitätsklinikum Augsburg Augsburg
- Medical center Klinikum Chemnitz gGmbH Chemnitz
- University medical center Universitätsklinikum Ulm Ulm
- University medical center Universitätsklinikum Freiburg Freiburg im Breisgau
- University medical center Universitätsklinikum Frankfurt Frankfurt a.M.
- Medical center Gesundheit Nordhessen Holding AG - Klinikum Kassel Kassel
- Medical center Klinikum Dortmund gGmbH – Westfälisches Kinderzentrum Dortmund
- University medical center Universitätsklinikum Erlangen Erlangen
- University medical center Johannes-Wesling-Klinikum Minden Minden
- University medical center Klinikum Oldenburg Oldenburg
- University medical center Universitätsmedizin Mannheim Mannheim
- University medical center Universitätsklinikum Aachen Aachen
- University medical center Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden
- University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
- University medical center Universitätsklinikum Jena Jena
- Medical center Städtische Klinikum Karlsruhe Karlsruhe
- University medical center Universitätsmedizin Göttingen Göttingen
- Medical center Gesundheit Nord gGmbH - Klinikum Bremen Mitte Bremen
- University medical center Universitätsklinikum Halle (Saale) Halle Saale
- University medical center Gemeinschaftskrankenhaus Herdecke Herdecke
- University medical center UKS – Universitätsklinikum des Saarlandes Homburg
- University medical center Dr. von Haunersches Kinderspital München
- Medical center SLK-Kliniken Heilbronn GmbH Heilbronn
- University medical center Universitätsklinikum Düsseldorf Düsseldorf
- Medical center Evangelisches Klinikum Bethel Bielefeld
- University medical center Universitätsklinikum Heidelberg Heidelberg
- Medical center Städtisches Klinikum Braunschweig gGmbH Braunschweig
- University medical center Klinikum München Rechts der Isar der Technischen Universität München München
- University medical center Das Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel
- University medical center Universitätsklinikum Leipzig Leipzig
- Medical center Helios Klinikum Erfurt Erfurt
- University medical center Universitätsklinikum Essen Essen
- University medical center Universitätsklinikum Münster Münster
- University medical center Medizinische Hochschule Hannover Hannover
- University medical center Das Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck
- University medical center Gemeinschaftsklinikum Mittelrhein gGmbH - Kemperhof Koblenz
- Medical center Sana Kliniken Duisburg GmbH Duisburg
- University medical center Universitätsklinikum Tübingen Tübingen
- University medical center Klinikum der Justus-Liebig-Universität Gießen Gießen
- University medical center Universitätsklinikum Gießen und Marburg GmbH Marburg
- University medical center Universitätsmedizin Rostock Rostock
- Medical center Helios Kliniken Krefeld GmbH Krefeld
- Medical center Kliniken der Stadt Köln gGmbH Köln
- University medical center Univ.-Kinderklinik Bonn Bonn
- Medical center Helios Kliniken Schwerin GmbH Schwerin
- Medical center Carl-Thiem-Klinikum Cottbus gGmbH Cottbus
- University medical center Universitätsklinikum Mainz Mainz
- Medical center Asklepios Klinik Sankt Augustin GmbH Sankt Augustin
- Medical center Helios Klinikum Berlin-Buch Berlin
- Medical center Klinikum Stuttgart Stuttgart
- Medical center Schön Klinik Vogtareuth Vogtareuth
- Medical center Klinikum Wolfsburg Wolfsburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2019-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 6000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- 21 Years
- Additional Inclusion Criteria:
- Diagnosis of LGG by neuropathology or neuroradiology as approved by the pertinent reference Centers, Age from birth to 21 years, signed informed consent by patients and parents
Exclusion Criteria
Diagnosis of a different brain tumor
Addresses
Primary Sponsor
- Address:
- Charité - Universitätsmedizin BerlinPD Dr. Pablo Hernáiz DrieverAugustenbruger Platz 113353 BerlinGermany
- Telephone:
- 030-450666829
- Fax:
- 030-4507566829
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité - Universitätsmedizin BerlinPD Dr. Pablo Hernáiz DrieverAugustenburger Platz 110585 BerlinGermany
- Telephone:
- 030 450666829
- Fax:
- 030 4507566829
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Contact for Public Queries
- Address:
- Charité - Universitätsmedizin BerlinPD Dr. Pablo Hernáiz DrieverAugustenbruger Platz 113353 BerlinGermany
- Telephone:
- 030-450666829
- Fax:
- 030-4507566829
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Principal Investigator
- Address:
- Charité - Universitätsmedizin BerlinPD Dr. Pablo Hernáiz DrieverAugustenburger Platz 110585 BerlinGermany
- Telephone:
- 030 450666829
- Fax:
- 030 4507566829
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Deutsche KinderkrebsstiftungAdenauerallee 13453113 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Charité-Universitätsmedizin BerlinAugustenburger Platz 113353 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-02-07
- Ethics committee number:
- EA2/030/19
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-03-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Data of patients will be shared anonymously upon approved request. The protocol of the registry is freely available.
Study protocol and other study documents
- Study protocols:
- LOGGIG Registerprotokoll V1.1
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry