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NCT Number: NCT05259605

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

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.

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Key information

Conditions

Glioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Choroid Plexus Tumor Diffuse Midline Glioma, H3 K27M-Mutant Embryonal Tumor Ependymoma Germ Cell Tumor Glioneuronal Tumor Hemangioblastoma Hemangioma Hemangioma, Capillary Hemangiopericytoma Melanocytic Tumor of CNS Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pineal Tumor Pineal Tumors Pinealoma Tumor of the Sellar Region

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Universitaetsklinik, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Observational

Other

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.

Primary outcomes

  1. Best overall and objective response

    Time frame: Followed up for 10 years

    Recorded from the date start of an anti-tumor therapy until disease progression or start of a new anti-tumor therapy.

  2. Progression free survival

    Time frame: Followed up for 10 years

    From the date of start of the anti-tumor therapy until the date of first objective progression as determined by the local investigator or the date of patient's death whichever occurs first. Patients will be followed up for 5 years after enrolment.

  3. Overall Survival

    Time frame: Followed up for 10 years

    Calculated from the date of first pathological diagnosis of the brain tumour; Until the date of death from any cause

  4. Patient and Disease Characteristics

    Time frame: At enrolment and updated every 6 months during follow-up, up to 10 years

    Eligibility, demographics, comorbidities, molecular data

Secondary outcomes

  1. Comparison of patient and disease characteristics between 2016 vs 2021 WHO classifications

    Time frame: At enrolment and during follow-up, up to 10 years

  2. Comparison of treatments and outcomes between classifications

    Time frame: From enrolment through follow-up, up to 10 years

  3. Neuroimaging features at diagnosis and progression

    Time frame: At initial diagnosis and at each documented progression, up to 10 years

  4. Generation of reference datasets for future trials

    Time frame: Throughout study duration, up to 10 years

Other outcomes

  1. Molecular profiling of tumour entities

    Time frame: At diagnosis and/or progression, up to 10 years (depending on tissue availability)

  2. Characterization of rare/undefined tumours (Cohort 17)

    Time frame: At diagnosis and during follow-up, up to 10 years

  3. Next Intervention-Free Survival (NIFS) - Cohort 16 only

    Time frame: From start of anti-tumour therapy until next intervention or death, up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

EORTC HQ

CONTACT

[email protected]

+32 2 774 1611

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study title

Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Diagnosed According to cIMPACT-NOW Recommendations and the 2021 WHO Classification

Important dates

Study start
2023
Primary completion
2027
Study completion
2038
First posted
Feb 28, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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