Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

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Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

Study Purpose

Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments. The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Newly diagnosed or recurrent primary brain tumours, notably those considered rare brain tumours or rare subtypes of common brain tumours.

- Archival tumour tissue from primary tumour available at the site.

Representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed.

- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

- Inclusion in interventional studies prior and after

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05259605
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Weller
Principal Investigator Affiliation	EORTC Study Coordinator
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Glioneuronal Tumor, Choroid Plexus Tumor, Pineal Tumors, Germ Cell Tumor, Tumor of the Sellar Region, Diffuse Midline Glioma, H3 K27M-Mutant, Ependymoma, Embryonal Tumor, Pineal Tumor, Hemangiopericytoma, Hemangioblastoma, Melanocytic Tumor of CNS

Arms & Interventions

Arms

: Gliomas, glioneuronal tumors, and neuronal tumors

: Choroid plexus tumors

: Embryonal tumors

: Cranial and paraspinal nerve tumors

: Mesenchymal, non-meningothelial tumors

: Melanocytic tumors

: Germ cell tumors

: Tumors of the sellar region

: Diffuse midline glioma, H3 K27M-mutant

: Diffuse hemispheric glioma, H3 G34-mutant

: Gliomas and glioneuronal tumors driven by MAPK pathway alterations

: Gliomas with MYB/MBL1 alterations

: Ependymoma

: Pineal tumors

: Meningioma with specific driver mutations

: Hemangiopericytoma (Solitary fibrous tumor)

: Hemangioblastoma

: Genetic tumor syndromes

Interventions

Other: - Observational

The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.