International registry for rare embryonal tumors of the central nervous system

Rare Embryonal Tumors of the Central Nervous System: International Registry

This study is creating a database to help doctors learn more about rare brain tumors in kids and young adults, so they can improve diagnosis and treatment, especially in places where information is limited.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 1 Day to 25 Years
• Sex: All
• Sponsor: Immune Oncology Research Institute (Academic / other)
• Locations: 11 sites (Yerevan and 10 other locations)
• Trial ID: NCT05711992 on ClinicalTrials.gov

What this trial studies

This international registry aims to create a comprehensive database of pediatric and young adult patients diagnosed with rare embryonal tumors of the central nervous system. It focuses on documenting clinical presentations, diagnostic challenges, treatment regimens, and patient outcomes for these rare tumors, which include ETMR, FOXR2-activated CNS neuroblastoma, and others. The registry seeks to evaluate prognostic factors and identify gaps in diagnosis and treatment, particularly in low- and middle-income countries where data is scarce. By gathering this information, the study aims to improve understanding and management of these rare conditions.

Who should consider this trial

Good fit: Ideal candidates for this registry are patients aged 25 years or younger diagnosed with specific rare embryonal tumors of the CNS since January 1, 2010.

Not a fit: Patients with CNS metastases of extracranial embryonal tumors will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved diagnosis and treatment strategies for patients with rare embryonal tumors.

How similar studies have performed: While there have been studies on rare embryonal tumors, this registry approach is novel and aims to fill significant gaps in existing research.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with rare embryonal tumors of CNS since 01.01.2010:

  * 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:

• CNS metastases of extracranial embryonal tumors

Where this trial is running

Yerevan and 10 other locations

• Hematology Center named after prof. R. Yeolyan — Yerevan, Armenia (Recruiting)
• Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Canada (Recruiting)
• Semmelweis University — Budapest, Hungary (Recruiting)
• National Cancer Institute, All India Institutes of Medical Sciences — New Delhi, India (Recruiting)
• Oncology Department of Golestan hospital — Tehran, Iran (Recruiting)
• IRCCS Istituto Ospedale Pediatrico Bambino Gesù — Rome, Italy (Recruiting)
• Hospital Civil de Guadalajara "Dr. Juan I. Menchaca" — Guadalajara, Mexico (Recruiting)
• Centro Médico ABC — Mexico City, Mexico (Recruiting)
• Hospital Nacional Alberto Sabogal Sologuren - EsSalud — Bellavista, Peru (Recruiting)
• Hospital Nacional Edgardo Rebagliati Martins — Lima, Peru (Recruiting)
• China Medical University Children's Hospital — Taichung, Taiwan (Recruiting)

Study contacts

• Principal investigator: Julieta Hoveyan, MD — Immune Oncology Research Institute, Yerevan, Armenia
• Study coordinator: Julieta Hoveyan, MD

Conditions Embryonal Tumor