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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study 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 locations and contacts

42 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official 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

Conditions

Glioma, Glioneuronal Tumor, Choroid Plexus Tumor, Pineal Tumors, Germ Cell Tumor, Tumor of the Sellar Region

Being tested

Observational

Keywords

Rare primary brain tumor, 2021 WHO Classification, molecular diagnosis, Gliomas, Choroid plexus tumors, Embryonal tumors, Pineal tumors

Medical subject headings

Glioma, Choroid Plexus Neoplasms, Pinealoma, Neoplasms, Germ Cell and Embryonal, Ependymoma, Hemangiopericytoma, Hemangioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ObservationalOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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

   Measured: Followed up for 10 years

4. Patient and Disease Characteristics

   Eligibility, demographics, comorbidities, molecular data

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Feb 2022
2. Study start21 Mar 2023
3. Primary completion30 Dec 2027 (estimated)
4. Study completion29 Jul 2038 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for GliomaStudies of the same condition, open and under way.
• More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.