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DRKS00019035

LOGGIC Core BioClinical Data Bank

Datenbasis: WHO (Import vom 18.04.2021)
Geändert: 28.03.2021
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

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

Interventions (Datenquelle: WHO)

Intervention 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)

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)
Exclusion criteria: any previous treatment with chemo/radio therapy, excluding surgery

Weitere Angaben zur Studie im WHO-Primärregister

http://www.drks.de/DRKS00019035

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

https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00019035

Weitere Informationen zur Studie

Registrationsdatum der Studie

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: Other;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Other

Phase (Datenquelle: WHO)

N/A

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

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Australia, Austria, Belgium, Czech Republic, 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)

Claudia
Caspar
Im Neuenheimer Feld 130.3
Hopp Kindertumorzentrum Heidelberg
claudia.caspar@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

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Hopp Kindertumorzentrum Heidelberg

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

S-064/2019