Rare Embryonal Tumors of the Central Nervous System: International Registry
NCT ID: NCT05711992
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-02-01
2033-02-28
Brief Summary
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Detailed Description
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Embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, CNS tumor with BCOR internal tandem duplication, and embryonal tumors not otherwise specified/not elsewhere classified (NOS/NEC) are extremely rare. Moreover, FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumor with BCOR internal tandem duplication were first described in the fifth edition of the WHO Classification of Tumors of the Central Nervous System, published in 2021. Because of the rarity of these tumors, randomized controlled clinical trials are extremely complicated to conduct. Considering the lack of studies from low- and middle-income countries (LMICs) it is not excluded that cases of rare embryonal tumors are more common than have been described in the literature. Hence, evidence can be generated through registry studies.
This is a multicenter international retrospective and prospective registry to collect and analyze data from pediatric and young adult patients diagnosed with rare CNS embryonal tumors. Patients will be recruited directly by participating centers and national study groups. Participating centers will collect and verify the informed consent of all prospective patients enrolled at their centers.
Patients diagnosed with rare embryonal tumors of the CNS (ETMR, FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, CNS tumor with BCOR internal tandem duplication, embryonal tumors NOS/NEC) since 01.01.2010 will be included. ETMR has been included in the WHO classification of CNS tumors since 2016 and encompasses three morphologically distinct embryonal tumors (Embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma (EBL) and medulloepithelioma (MEPL)) that were previously classified as CNS primitive neuroectodermal tumors (CNS-PNETs). These histological subtypes should also be included in the study. Considering the lack of molecular genetic tests done among retrospective cases, the investigators will also include all patients diagnosed with neuroblastoma and ganglioneuroblastoma.
The following data will be collected through questionnaires:
1. Patient characteristics
2. Characteristics of rare CNS embryonal tumors
3. Details of the diagnosis and treatment
4. Complications and late effects of treatment
5. Outcomes
6. Follow-up information
Quality control and data management will be conducted by the Immune Oncology Research Institute.
Conditions
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
* ETMR (including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma (EBL) and medulloepithelioma (MEPL) which were previously classified as CNS-PNETs)
* FOXR2-activated CNS neuroblastoma
* cribriform neuroepithelial tumor
* CNS tumor with BCOR internal tandem duplication
* all patients diagnosed with neuroblastoma and ganglioneuroblastoma with no molecular genetic tests available
* Patients ≤ 25 years of age
* Signed informed consent form for prospective patients ≥ 18 years of age
* Signed parental permission and child assent forms for prospective patients \< 18 years of age
Exclusion Criteria
1 Day
25 Years
ALL
No
Sponsors
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Immune Oncology Research Institute
OTHER
Responsible Party
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Principal Investigators
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Julieta Hoveyan, MD
Role: PRINCIPAL_INVESTIGATOR
Immune Oncology Research Institute, Yerevan, Armenia
Ruzanna Papyan, MD
Role: PRINCIPAL_INVESTIGATOR
Immune Oncology Research Institute, Yerevan, Armenia
Gevorg Tamamyan, MD, PhD, DSc
Role: STUDY_DIRECTOR
Immune Oncology Research Institute, Yerevan, Armenia
Locations
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Hematology Center named after prof. R. Yeolyan
Yerevan, , Armenia
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, , Canada
Semmelweis University
Budapest, , Hungary
National Cancer Institute, All India Institutes of Medical Sciences
New Delhi, , India
Oncology Department of Golestan hospital
Tehran, , Iran
IRCCS Istituto Ospedale Pediatrico Bambino Gesù
Rome, , Italy
Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
Guadalajara, , Mexico
Centro Médico ABC
Mexico City, , Mexico
Hospital Nacional Alberto Sabogal Sologuren - EsSalud
Bellavista, , Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, , Peru
China Medical University Children's Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Akash Kumar, MD
Role: backup
Sofia Aguilar Moreno, MD
Role: backup
Other Identifiers
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IMMONC0005
Identifier Type: -
Identifier Source: org_study_id
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