Rare Embryonal Tumors of the Central Nervous System: International Registry

NCT05711992 | Recruiting DMC

• 1 other identifier: IMMONC0005
• Study Type: observational
• Target: 300
• Locations: 9 countries
• Sites: 11

Brief Summary

Central nervous system (CNS) tumors are the most common solid malignancies among children. Although some types of CNS tumors like medulloblastomas and low-grade gliomas are widespread and well-studied, there is a huge number of rare diseases that need further research. This international registry aims to establish a large multicenter database of pediatric and young adult patients with rare embryonal tumors of the central nervous system and describe the clinical presentations, diagnostics, treatment regimens, and outcomes. Embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumor with BCOR internal tandem duplication are extremely rare embryonal tumors some of which were first described in the last edition of the World Health Organization (WHO) Classification of Tumors of the Central Nervous System. Objectives of the registry are 1) to evaluate prognostic factors, 2) to identify diagnostic and treatment gaps, 3) to investigate the characteristics and outcome of the disease with different treatment regimens, and 4) to generate data-based prospective diagnostic and treatment recommendations.

Conditions

Embryonal Tumor

Outcome Measures

Primary Outcomes (2)

• 3-year overall survival

  3 years

• 5-year overall survival

  5 years

Secondary Outcomes (3)

• Complete remission rate

  5 years

• 3-year event-free survival

  3 years

• 5-year event-free survival

  5 years

Eligibility Criteria

• Age: 1 Day - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with rare embryonal tumors

You may qualify if:

• 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

You may not qualify if:

• CNS metastases of extracranial embryonal tumors

Sponsors & Collaborators

• Immune Oncology Research Institute: lead

Study Sites (11)

Hematology Center named after prof. R. Yeolyan

Yerevan, 0014, Armenia

RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, K1H 8L1, Canada

RECRUITING

Semmelweis University

Budapest, 1085, Hungary

RECRUITING

National Cancer Institute, All India Institutes of Medical Sciences

New Delhi, 110029, India

RECRUITING

Oncology Department of Golestan hospital

Tehran, 16686 19551, Iran

RECRUITING

IRCCS Istituto Ospedale Pediatrico Bambino Gesù

Rome, 00163, Italy

RECRUITING

Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"

Guadalajara, 44340, Mexico

RECRUITING

Centro Médico ABC

Mexico City, 01120, Mexico

RECRUITING

Hospital Nacional Alberto Sabogal Sologuren - EsSalud

Bellavista, 07011, Peru

RECRUITING

Hospital Nacional Edgardo Rebagliati Martins

Lima, 15072, Peru

RECRUITING

China Medical University Children's Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Julieta Hoveyan, MD

  Immune Oncology Research Institute, Yerevan, Armenia

  PRINCIPAL INVESTIGATOR

• Ruzanna Papyan, MD

  Immune Oncology Research Institute, Yerevan, Armenia

  PRINCIPAL INVESTIGATOR

• Gevorg Tamamyan, MD, PhD, DSc

  Immune Oncology Research Institute, Yerevan, Armenia

  STUDY DIRECTOR

Central Study Contacts

Julieta Hoveyan, MD

CONTACT

+374 10 28 38 00; julia.hoveyan95@gmail.com

Ruzanna Papyan, MD

CONTACT

+374 10 28 38 00; ruzannapapyan92@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

ME (2); HU (1); IR (1); IN (1); TW (1); IT (1); AR (1); CA (1); PE (2)