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DRKS00019035

LOGGIC Core BioClinical Data Bank

Datenbasis: WHO (Import vom 20.03.2024)
Geändert: 08.03.2024, 01:00
Krankheitskategorie:

Health conditions (Datenquelle: 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 (Datenquelle: 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 (Datenquelle: 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

Weitere Angaben zur Studie im WHO-Primärregister

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

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00019035
Weitere Informationen zur Studie

Datum der Studienregistrierung

29.11.2019

Einschluss der ersten teilnehmenden Person

05.04.2019

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

LOGGIC Core BioClinical Data Bank - LOGGIC Core

Studientyp (Datenquelle: WHO)

observational

Design der Studie (Datenquelle: WHO)

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

Primäre Endpunkte (Datenquelle: WHO)

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

Sekundäre Endpunkte (Datenquelle: WHO)

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

Kontakt für Auskünfte (Datenquelle: WHO)

The Brain Tumour CharityHartshead House

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

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

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

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.

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

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

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

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

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

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

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

S-064/2019
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