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DRKS00019035

LOGGIC Core BioClinical Data Bank

Base di dati: WHO (Importata da 25.04.2024)
Cambiato: 12 apr 2024, 01:00
Categoria di malattie:

Health conditions (Fonte di dati: 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 (Fonte di dati: 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 (Fonte di dati: 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

Altri dati sulla sperimentazione nel registro primario dell’OMS

http://drks.de/search/en/trial/DRKS00019035

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00019035
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

29 nov 2019

Inserimento del primo partecipante

5 apr 2019

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: WHO)

LOGGIC Core BioClinical Data Bank - LOGGIC Core

Tipo di sperimentazione (Fonte di dati: WHO)

observational

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: othe

Punti finali primari (Fonte di dati: WHO)

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

Punti finali secondari (Fonte di dati: WHO)

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

Contatto per informazioni (Fonte di dati: WHO)

The Brain Tumour CharityHartshead House

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

http://drks.de/search/en/trial/DRKS00019035#studyResults

Informazioni sulla disponibilità dei dati dei singoli partecipanti

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.

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: WHO)

Australia, Austria, Belgium, Czechia, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni generali (Fonte di dati: WHO)

Carina
Bodden
Im Neuenheimer Feld 130.3
Hopp Kindertumorzentrum Heidelberg
+496221564780
carina.bodden@kitz-heidelberg.de

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Olaf
Witt
Im Neuenheimer Feld 430
Hopp Kindertumorzentrum Heidelberg (KiTZ)
+49 6221 42-3570
o.witt@kitz-heidelberg.de

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

S-064/2019
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