Observational assessment of treatment outcomes for patients with primary brain tumors
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification
European Organisation for Research and Treatment of Cancer - EORTC · NCT05259605
This study looks at how well treatments work for people with rare primary brain tumors using new classification guidelines to see if they help doctors group patients better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC (network) |
| Locations | 42 sites (Innsbruck and 41 other locations) |
| Trial ID | NCT05259605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the treatment and outcomes of patients diagnosed with rare primary brain tumors using the new 2021 WHO classification and cIMPACT-NOW recommendations. It seeks to determine if the updated classification leads to more consistent patient groupings compared to the previous 2016 classification. By collecting data on treatment experiences and outcomes, the study will help establish provisional guidelines for managing these newly defined tumor entities. The focus is on newly diagnosed or recurrent tumors, with an emphasis on those considered rare.
Who should consider this trial
Good fit: Ideal candidates include individuals with newly diagnosed or recurrent primary brain tumors, particularly rare types.
Not a fit: Patients with common brain tumors or those without available archival tumor tissue may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer treatment guidelines and improve outcomes for patients with rare primary brain tumors.
How similar studies have performed: Other studies have shown success in using updated classifications to improve treatment outcomes, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
* Age ≥ legal age of consent * Newly diagnosed or recurrent primary brain tumours within one of the 17 cohorts of interest * 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. Exception: only tissue from first surgery is allowed for Cohort 16. * Available MRI/CT scans from primary brain tumour at initial diagnosis * Patient's consent Deceased patient: The clinical data and/or biological material and/or CT/MRI/PET images can be accessed and used if at least one of the following three conditions is met: * The patient agreed beforehand in his/her lifetime to a further use of his/her data and/or biological material and/or CT/MRI/PET images, or, * There is consent of a relative to use data and/or biological material and/or CT/MRI/PET images of the deceased patient, or, * There is a reference to a corresponding legal declaration covering the exemption in case of the impossibility or disproportion of getting access to an informed consent (e.g., causing strain on relatives of deceased patients). Additionally, in all cases the following three points need to be fulfilled: * No documentation of previous objection of the patient to the (re-)use of their data, biological material, CT/MR/PET images for research purposes * A notification to an ethics committee for the re-use of these data, biological material and CT/MRI/PET images * Any other national requirements are fulfilled, if applicable
Where this trial is running
Innsbruck and 41 other locations
- Innsbruck Universitaetsklinik — Innsbruck, Austria (RECRUITING)
- Universitaetsklinikum Wien - AKH unikliniken — Vienna, Austria (RECRUITING)
- Onze Lieve Vrouw Ziekenhuis — Aalst, Belgium (RECRUITING)
- Institut Jules Bordet — Anderlecht, Belgium (RECRUITING)
- Universitair Ziekenhuis Brussel — Brussels, Belgium (RECRUITING)
- C.H.U. Sart-Tilman — Liège, Belgium (RECRUITING)
- AZ Delta - Campus Rumbeke — Roeselare, Belgium (RECRUITING)
- CHU Lyon - Hopital neurologique Pierre Wertheimer — Lyon, France (RECRUITING)
- Hopital de La Timone — Marseille, France (RECRUITING)
- Hopital la Pitie-Salpetriere — Paris, France (RECRUITING)
- Knappschaft Krankenhaus Langendreer — Bochum, Germany (RECRUITING)
- Universitaetsklinikum Bonn — Bonn, Germany (RECRUITING)
- Universitaetsklinikum Koeln — Cologne, Germany (RECRUITING)
- Universitaetsklinikum - Essen — Essen, Germany (RECRUITING)
- University Hospital Frankfurt -Senckenberg Institute of Neurooncology — Frankfurt, Germany (RECRUITING)
- Universitaetsklinikum Jena — Jena, Germany (RECRUITING)
- Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie — Leipzig, Germany (RECRUITING)
- Universitaetsklinikum Regensburg — Regensburg, Germany (RECRUITING)
- Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A. — Athens, Greece (RECRUITING)
- Ospedale Bellaria-Bologna — Bologna, Italy (RECRUITING)
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (RECRUITING)
- Istituto Neurologico Carlo Besta — Milan, Italy (RECRUITING)
- IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
- Istituto Oncologico Veneto — Padova, Italy (RECRUITING)
- IRCCS-Regina Elena National Cancer Center — Roma, Italy (RECRUITING)
- Ospedale San Giovanni - Dipartimento Neuroscienze — Torino, Italy (RECRUITING)
- The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis — Amsterdam, Netherlands (RECRUITING)
- Leiden University Medical Centre — Leiden, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
- Oslo University Hospital - Radiumhospitalet — Oslo, Norway (RECRUITING)
- Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria — Lisbon, Portugal (RECRUITING)
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE — Lisbon, Portugal (RECRUITING)
- Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain (RECRUITING)
- Hospital Clinic de Barcelona — Barcelona, Spain (RECRUITING)
- Hospital De La Santa Creu I Sant Pau — Barcelona, Spain (RECRUITING)
- Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) — Barcelona, Spain (RECRUITING)
- Hospital Duran i Reynals — L'Hospitalet de Llobregat, Spain (RECRUITING)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (RECRUITING)
- UniversitaetsSpital Zurich - Neurology Clinic — Zurich, Switzerland (RECRUITING)
- NHS Lothian - The Royal Infirmary Of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
- Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care — Newcastle upon Tyne, United Kingdom (RECRUITING)
- Nottingham University Hospitals NHS Trust - City Hospital — Nottingham, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Michael Weller — EORTC Study Coordinator
- Study coordinator: EORTC HQ
- Email: eortc@eortc.org
- Phone: +32 2 774 1611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma, Glioneuronal Tumor, Choroid Plexus Tumor, Pineal Tumors, Germ Cell Tumor, Tumor of the Sellar Region, Diffuse Midline Glioma, H3 K27M-Mutant, Ependymoma