Low Grade Glioma in Children (LOGGIC) Core BioClinical Data Bank

ISRCTN	ISRCTN14148692
DOI	https://doi.org/10.1186/ISRCTN14148692
Integrated Research Application System (IRAS)	358899
Central Portfolio Management System (CPMS)	73697
Grant Code	CRCPJT\100015
Sponsor	University of Birmingham
Funder	Cancer Research UK

Submission date: 08/09/2026
Registration date: 06/10/2026
Last edited: 06/10/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In this study, researchers are trying to learn more about the specific changes in genetic information and what is driving the change in low grade gliomas (LGGs).
The LOGGIC Core BioClinical Data Bank (LOGGIC Core) is a collection of information on the genetic changes in LGG tumours, designed to improve our understanding of LGGs in children. Using this information, we want to help develop new treatment strategies for future patients. We want to personalise tumour treatment based on their genetic information, such as whether a tumour has a certain change and therefore could respond well or poorly to a particular treatment. Further to this, the study hopes to identify tests (known as biomarkers) that predict LGG disease progression, and the best treatment option for this.

Who can participate?
Children and young adults aged 0-21 years with low grade glioma. A doctor will check if someone is eligible to take part.

What does the study involve?
If you join the study, DNA will be extracted from samples of your tumour tissue and blood to look for changes in your DNA. All samples will usually be taken at the same time as routine procedures. The results will be stored as part of a DataBank for researchers to use to study LGGs.

What are the possible benefits and risks of participating?
The main benefit is to help in the development of new treatments for LGG in the future. The risks are small as all samples will be taken at the same time as routine procedures, therefore participation in the study does not create additional risks.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
October 2026 to October 2031

Who is funding the study?
Cancer Research UK

Who is the main contact?
LOGGICCore@trials.bham.ac.uk

Contact information

Prof Darren Hargrave
Principal investigator

Great Ormond Street Hospital for Children
London
WC1N 3JH
United Kingdom

ORCID ID	0000-0001-8219-9807
Email	Darren.Hargrave@gosh.nhs.uk

Study Team
Public, Scientific

Children’s Cancer Trials Team (CCTT-C), Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	LOGGICCore@trials.bham.ac.uk

Study information

Primary study design	Observational
Observational study design	Longitudinal study
Scientific title	Low Grade Glioma in Children (LOGGIC) Core BioClinical Data Bank
Study acronym	LOGGIC Core
Study objectives	1. Establishment of logistics for tissue sample submission, analysis of genetic changes in tumours, identification of genetic changes in tumours which could be targeted by particular treatments, and establishment of a clinical and genetic data bank for children and young people with low grade glioma (LGG). 2. To collect information about genetic changes in the tumours of patients with LGG at diagnosis and optionally at relapse. This information will then be used to analyse biomarkers (indicators of what is happening in the tumour) and clinical outcome, and will also be provided to other studies in the LOGGIC series (where patients consent to participate in these related studies). 3. To collect baseline histological and clinical follow-up data. 4. To explore improvement of diagnostic accuracy for all LGG patients involved in the study by adding genetic information to reference histological and radiological evaluation, and to investigate the existence of possible new, genetically-defined subtypes of LGG. 5. To describe clinically relevant target patterns and frequencies in children and young people with LGG, including identification of new therapeutic targets. 6. To identify biomarkers to predict treatment response and natural course of disease, by linking histopathological and genetic data with radiological and clinical follow-up data. This includes, but is not limited to, RNA-seq expression signature analysis (identifying groups of genes with correlated expression patterns) for particular phenotypes (characteristics), identified through RNA and/or single cell sequencing of fresh frozen tumour tissue, as well as other high-throughput methods (automatic systems to rapidly conduct different scientific tests) using frozen tissue for therapeutic target discovery and validation. 7. To explore feasibility of liquid biopsy analysis (using liquid samples to test for signs of tumours) on different sources including blood and cerebrospinal fluid (CSF) collected during routine procedures as potential biomarkers for diagnosis and response to treatment, as well as other exploratory biological studies. 8. To set a drug testing and model using viable tumour tissue. 9. To establish a LOGGIC biobank and use the Hannover Unified Biobank in Germany to store extracted DNA and RNA from remaining tissue after all other objectives have been addressed.
Ethics approval(s)	Approved 08/07/2026, South Central - Berkshire Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; berkshire.rec@hra.nhs.uk), ref: 26/SC/0124
Health condition(s) or problem(s) studied	Low-grade glioma
Methodology	Where a patient has been diagnosed with low grade glioma (LGG) and the treating doctor feels they are eligible for the study, the doctor will discuss the study with them, including whether their care may need to transfer to a different doctor or hospital if the study is not offered at their current hospital or if the treating doctor is not an investigator for the study. The patient and/or parent/guardian will be provided with an age-appropriate information sheet and given time to consider whether they would like to participate in the study. Patients and/or parents/guardians will be given as much time as possible to consider the study, in all cases at least 24 hours. The patient and/or parent/guardian will then be given the opportunity to discuss the study further and have any questions answered. If the patient and/or parent/guardian agrees to take part in the study, informed consent will then be obtained by a suitably qualified member of the research team, who has been delegated this task, via completion of an informed consent form. Following consent, baseline data will be collected and entered into the study database. Fresh frozen and paraffin embedded tumour samples which were collected during a previous surgery or biopsy will be sent to Great Ormond Street Hospital (GOSH.) A blood sample will also be collected and sent to GOSH; however, this will only be collected at the same time as routine blood collection. If a patient has previously had molecular profiling performed on tumour samples as part of their standard care, results from this testing will be sent to GOSH by the local genomic laboratory hub who previously analyses samples, for use in the study to avoid duplication of tests which have already been performed. GOSH will perform first level molecular diagnostics, which involves performing genetic analyses on the paraffin embedded tumour samples. As part of their analyses, GOSH will also centrally confirm the local hospital's diagnosis of LGG. Following this, GOSH will send the samples to the second level molecular diagnostics facility in Heidelberg, Germany. Here, further genetic analyses will be performed on the blood and tumour samples. Results from these tests will be returned to the treating doctor, who will have responsibility for deciding on treatment options for the patient, which may include further surgery, chemotherapy, radiotherapy or another clinical trial, which may offer a treatment targeting the genetic alterations found in the patient's tumour. Where cerebrospinal fluid (CSF) is collected as part of routine treatments, any excess CSF which is not needed for routine diagnostics will be sent to GOSH, who will then send samples to Heidelberg for analysis, including genetic analysis. This aspect of the study is optional, and patients can participate in the rest of the study without consenting to analysis of CSF samples. Follow-up data will be collected for up to 5 years, which will include information about any treatments the patient receives, information about their tumour and survival data. This will be used to analyse clinical outcomes. The research team at the hospital site will enter this data onto the study database as/when required. If the patient experiences any relapse or progression of their tumour whilst participating in the study, tumour samples from any routine surgery or biopsy, as well as an additional blood sample collected at the same time as routine blood collection, will undergo first and second level molecular diagnostics, as described above. If any genetic alterations are identified which are also present in the patient's blood sample (i.e., in all of their body's cells), and the patient's treating doctor feels these are significant and may have implications for the patient and their family, the treating doctor may refer the patient and/or their parent/guardian to the NHS clinical genetics service to discuss further. The study is open in several countries across Europe and will recruit thousands of LGG cases, which will help to understand more about molecular subgroups of LGG and associated clinical outcomes. The data generated in the study will be analysed by the international study management team at Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ), Germany and Westfalische Wilhelms-Universitat Muenster (WWU), Muenster, Germany.
Intervention type	Other
Primary outcome measure(s)	Molecular characterisation of paediatric low-grade glioma using prognostic and predictive molecular biomarkers at diagnosis and/or relapse
Key secondary outcome measure(s)
Completion date	31/10/2031

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	0 Years
Upper age limit	21 Years
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Age <21 years 2. 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; exceptions (i.e., MRI-based diagnosis) can be accepted only where a biopsy would pose an unacceptable risk to damage of eloquent brain structures 3. 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 4. Before patient registration, written informed consent, including data and tumour material transfer, must be given according to ICH/GCP and national/local regulations 5. Residency in one of the participating countries of LOGGIC Core
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/10/2026
Date of final enrolment	30/09/2031

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland

Study participating centres

Alder Hey Children's Hospital

Eaton Road
West Derby
Liverpool
L12 2AP
England

Birmingham Childrens Hospital

Steelhouse Lane
Birmingham
B4 6NH
England

Bristol Royal Hospital for Children

Upper Maudlin Street
Bristol
BS2 8BJ
England

The Christie

550 Wilmslow Road
Withington
Manchester
M20 4BX
England

Royal Victoria Infirmary

Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England

Great Ormond Street Hospital for Children

Great Ormond Street
London
WC1N 3JH
England

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
England

Leeds General Infimary

Great George Street
Leeds
LS1 3EX
England

Noahs Ark Childrens Hospital for Wales

Cardiff & Vale University Health Bd
Heath Park
Cardiff
CF14 4XW
Wales

Queens Medical Centre

Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
England

The Royal Belfast Hospital for Sick Children

274 Grosvenor Road
Belfast
BT12 6BA
Northern Ireland

Royal Hospital for Children and Young People

50 Little France Crescent
Edinburgh
Lothian
EH16 4TJ
Scotland

Royal Manchester Children's Hospital

Oxford Road
Manchester
M13 9WL
England

Royal Marsden Hospital

Downs Road
Sutton
SM2 5PT
England

Sheffield Childrens Hospital

Western Bank
Sheffield
S10 2TH
England

Southampton General Hospital

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request. Access to the data is controlled through requests to the ‘Data and Sample Access Advisory Board’ for the study. Requests can be submitted initially to the Study Mailbox, where they will be referred to the study advisory board.

Editorial Notes

08/09/2026: Study's existence confirmed by the NIHR.