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DRKS00019035

LOGGIC Core BioClinical Data Bank

Data source: WHO (Imported from 18.01.2022)
Changed: 18.01.2022
Disease category:

Health conditions (Data source: 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 (Data source: 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 (Data source: 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

Further information on the trial in WHO primary registry

http://www.drks.de/DRKS00019035

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

29.11.2019

Incorporation of the first participant

05.04.2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

LOGGIC Core BioClinical Data Bank - LOGGIC Core

Type of trial (Data source: WHO)

observational

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

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

Secundary end point (Data source: WHO)

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

Contact information (Data source: WHO)

The Brain Tumour CharityHartshead House

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

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

Contact for further information on the trial

Contact for general information (Data source: WHO)

Claudia
Caspar
Im Neuenheimer Feld 130.3
Hopp Kindertumorzentrum Heidelberg
claudia.caspar@kitz-heidelberg.de

Contact for scientific information (Data source: WHO)

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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Hopp Kindertumorzentrum Heidelberg

Further trial identification numbers

Secondary ID (Data source: WHO)

S-064/2019