to study search History

LOGGIC Core BioClinical Data Bank

Organizational Data

DRKS-ID:
DRKS00019035
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2019-11-29
Last update in DRKS:
2023-01-10
Registration type:
Retrospective

Acronym/abbreviation of the study

LOGGIC Core

URL of the study

https://www.kitz-heidelberg.de/en/clinical-studies/molecular-diagnostics-studies/loggic-core

Brief summary in lay language

Establishment of a molecular and clinical database for pediatric low-grade gliomas. The data will be used to improve the understanding of the tumor biology of the disease. For this purpose, state-of-the-art techniques are used to obtain a "fingerprint" of each individual tumor.

Brief summary in scientific language

The overall aim of the LOGGIC Core BioClinical Data Bank (LOGGIC Core) is to set up a molecular and clinical data bank for pediatric low grade gliomas (LGG). The data will be used to enhance the understanding of tumorbiology of the disease but also to correlate molecular subgroups of LGG with clinical outcome. In addition, the registry will serve as a data bank for providing molecular data for other trials of the LOGGIC program. Tumor samples will be collected as part of the routine standard of care clinical management of LGG patients. The registry is a non-interventional collection of molecular and clinical data. State-of-the-art molecular profiling technologies will be applied to get a “fingerprint” of each individual tumour. The treating physicians will have access to the molecular information/targets of their patients and carry the full responsibility as to whether and in which way they use these data for clinical use. LOGGIC Core will collect clinical and histological baseline data and provide molecular genetic data to other trials of the LOGGIC program including the LOGGIC Europe and other clinical trials. As such, LOGGIC Core is an integral and essential part of the wider LOGGIC concept. Any patient with newly diagnosed LGG either by histology and/or imaging will be registered into LOGGIC Core after informed consent. With registration in LOGGIC Core, formalin-fixed paraffin-embedded (FFPE) and fresh-frozen tissue and blood need to be submitted for molecular diagnostics .

Health condition or problem studied

Free text:
Low Grade Glioma
ICD10:
D33 - Benign neoplasm of brain and other parts of central nervous system
ICD10:
D43 - Neoplasm of uncertain or unknown behaviour of brain and central nervous system
Healthy volunteers:
No

Interventions, Observational Groups

Arm 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.

Endpoints

Primary outcome:
Establishment of a molecular and clinical data base for pediatric low grade glioma
Secondary outcome:
To collect molecular tumour characteristics of LGG patients for exploratory analysis of biomarker and clinical outcome.

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Aachen
  • Medical center Augsburg
  • University medical center Charité Berlin
  • Medical center Helios Klinikum Berlin-Buch
  • Medical center Evangelisches Klinikum Bethel Bielefeld
  • University medical center Bonn
  • Medical center Braunschweig
  • Medical center Klinikum Bremen Mitte Bremen
  • Medical center Chemnitz
  • Medical center Carl Thiem-Klinikum Cottbus
  • Medical center Städtische Kinderklinik Dortmund
  • University medical center Dresden
  • Medical center Sana Kliniken Duisburg
  • Medical center Helios-Klinikum Erfurt
  • University medical center Erlangen
  • University medical center Frankfurt
  • University medical center Freiburg
  • University medical center Gießen
  • University medical center Göttingen
  • University medical center Greifswald
  • University medical center Halle (Saale)
  • University medical center UKE Hamburg
  • University medical center Med. Hochschule Hannover
  • University medical center Heidelberg
  • Medical center Klinik Gesundbrunnen Heilbronn
  • University medical center Homburg (Saar)
  • University medical center Jena
  • Medical center Städt. Klinikum Karlsruhe
  • Medical center Kassel
  • University medical center ULSH Campus Kiel Kiel
  • Medical center GK Mittelrhein Koblenz
  • Medical center Städt. Kliniken Köln
  • Medical center Helios Klinikum Krefeld
  • University medical center Leipzig
  • University medical center UK-SH Campus Lübeck Lübeck
  • University medical center Madgeburg
  • University medical center Mainz
  • University medical center Mannheim
  • Medical center Minden
  • University medical center TU München, Schwabing München
  • University medical center Münster
  • Medical center Elisabeth-Krankenhaus Oldenburg
  • University medical center Regensburg
  • University medical center Rostock
  • Medical center Asklepios Klinik St. Augustin
  • Medical center Olgahospital Stuttgart
  • University medical center Tübingen
  • University medical center Ulm
  • University medical center Würzburg
  • Medical center Wolfsburg
  • Medical center Gemeinschaftskrankenhaus Herdecke

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2019-04-05
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
5000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
20 Years
Additional 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

Addresses

Primary Sponsor

Hopp Kindertumorzentrum Heidelberg
Prof. Dr. Olaf Witt
Im Neuenheimer Feld 430
69120 Heidelberg
Germany
Telephone:
+49 6221-42-3570
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Hopp Kindertumorzentrum Heidelberg (KiTZ)
Prof. Dr. Olaf Witt
Im Neuenheimer Feld 430
69120 Heidelberg
Germany
Telephone:
+49 6221 42-3570
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Hopp Kindertumorzentrum Heidelberg
Dr. Carina Bodden
Im Neuenheimer Feld 130.3
69120 Heidelberg
Germany
Telephone:
+496221564780
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Hopp Kindertumorzentrum Heidelberg (KiTZ)
Prof. Dr. Olaf Witt
Im Neuenheimer Feld 430
69120 Heidelberg
Germany
Telephone:
+49 6221 42-3570
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

The Brain Tumour CharityHartshead House
61-65 Victoria Road
GU14 7PA Hampshire
Telephone:
+44 (0) 1252 418190
Fax:
No Entry
Contact per E-Mail
URL:
http://thebraintumourcharity.org

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-01-28
Ethics committee number:
S-064/2019
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-02-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
- 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.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
2023
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry