Health conditions
(Source de données: WHO)
Low Grade Glioma
D33
D43;Benign neoplasm of brain and other parts of central nervous system;Neoplasm of uncertain or unknown behaviour of brain and central nervous system
Interventions (Source de données: WHO)
Group 1: 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.
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: All
Maximum age: 20 Years
Minimum age: None
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 at relapse/progression
- At primary diagnosis:
- Histologically verified low-grade glioma / glioneuronal tumour WHO
grade I or II.
- Fresh frozen and paraffin tumour material together with blood available
for molecular diagnostics.
-At relapse/progression:
-Fresh frozen and paraffin tumour material together with blood available
for molecular diagnostics from primary diagnosis and/or current episode
(preferably) of relapse/progression.
- No exceptions for the submission of fresh frozen and paraffin tumour
material with blood
- In case that the date of diagnosis is earlier than 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.
- Residency in one of the participating countries of LOGGIC Core.
Exclusion criteria: No LGG
-
Plus d’informations sur l’étude
Date d’enregistrement de l’étude
29 nov. 2019
Intégration du premier participant
5 avr. 2019
Statut de recrutement
Recruiting
Titre scientifique
(Source de données: WHO)
LOGGIC Core BioClinical Data Bank - LOGGIC Core
Type d’étude
(Source de données: WHO)
observational
Conception de l’étude
(Source de données: WHO)
Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: othe
Points finaux primaires
(Source de données: WHO)
Establishment of a molecular and clinical data base for pediatric low grade glioma
Points finaux secondaires
(Source de données: WHO)
To collect molecular tumour characteristics of LGG patients for exploratory analysis of biomarker and clinical outcome.
Contact pour informations
(Source de données: WHO)
The Brain Tumour CharityHartshead House
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
Yes
- Will individual participant data be available? Yes
- What data in particular will be shared? Individual participant data collected in this register, after deidentification
- What other documents will be available? Study protocol
- When will data be available? Immediately; no end date
- With whom? Investigators whose proposed use of the data has been approved by an independent review committee (LOGGIC Core Data and Sample Access Advisory Board) identified for this purpose
- For what types of analyses? To achieve aims in the approved proposal
- By what mechanism will data be made available? Proposals should be directed to loggic@kitz-heidelberg.de . To gain access, data requestors will need to sign a data protection agreement.
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: WHO)
Australia, Austria, Belgium, Czechia, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Carina
Bodden
Im Neuenheimer Feld 130.3
Hopp Kindertumorzentrum Heidelberg
+496221564780
carina.bodden@kitz-heidelberg.de
Contact pour des informations scientifiques
(Source de données: WHO)
Olaf
Witt
Im Neuenheimer Feld 430
Hopp Kindertumorzentrum Heidelberg (KiTZ)
+49 6221 42-3570
o.witt@kitz-heidelberg.de
Plus de numéros d’identification d’étude
Secondary ID (Source de données: WHO)
S-064/2019
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