Health TrialsbyHealthPanel

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

ConditionsGliomaGlioneuronal TumorChoroid Plexus TumorPineal TumorsGerm Cell TumorTumor of the Sellar RegionDiffuse Midline Glioma, H3 K27M-MutantEpendymomaEmbryonal TumorPineal TumorHemangiopericytomaHemangioblastomaMelanocytic Tumor of CNS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Adult patients with newly diagnosed or recurrent primary brain tumours, notably those considered to be very rare brain tumours or rare subtypes of common brain tumours will be included. Patients diagnosed between 2011 and 2025.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Observational

    Other intervention

    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.

Treatment groups

1,650 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Group A: "Molecular" Gliobastomas, IDH-wildtype1 intervention
Group B: Paediatric-type diffuse low-grade gliomas0 interventions
Group C: Paediatric-type diffuse high-grade gliomas0 interventions
Group D: Circumscribed astrocytic gliomas0 interventions
Group E: Glioneuronal and neuronal tumours0 interventions
Group F: Ependymal tumours0 interventions
Group G: Choroid plexus tumours0 interventions
Group H: Embryonal tumours0 interventions
Group I: Pineal tumours0 interventions
Group J: Meningiomas with specific driver mutations and/or grade 30 interventions
Group K: Mesenchymal, non-meningothelial tumours0 interventions
Group L: Germ cell tumours0 interventions
Group M: Primary brain tumour with BRAF mutation0 interventions
Group N: Primary brain tumour with NTRK fusion0 interventions
Group O: Primary brain tumour with known germline mutation or family history of a primary brain tumour0 interventions
Group P: Astrocytoma, IDH-mutant, CNS WHO grade 4.0 interventions
Group Q: Previously poorly or undefined tumour entities.0 interventions

Trial outcomes

Primary outcomes

1

Best overall and objective response

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

Time frame
Followed up for 10 years
2

Progression free survival

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.

Time frame
Followed up for 10 years
3

Overall Survival

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

Time frame
Followed up for 10 years
4

Patient and Disease Characteristics

Eligibility, demographics, comorbidities, molecular data

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Organisation for Research and Treatment of Cancer - EORTC

Lead sponsor

Source ClinicalTrials.gov
Apply now