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Recruiting NCT05711992

NCT05711992 Rare Embryonal Tumors of the Central Nervous System: International Registry

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Clinical Trial Summary
NCT ID NCT05711992
Status Recruiting
Phase
Sponsor Immune Oncology Research Institute
Condition Embryonal Tumor
Study Type OBSERVATIONAL
Enrollment 300 participants
Start Date 2023-02-01
Primary Completion 2033-02

Eligibility & Interventions

Sex All sexes
Min Age 1 Day
Max Age 25 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 300 participants in total. It began in 2023-02-01 with a primary completion date of 2033-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Julieta Hoveyan, MD

✉ julia.hoveyan95@gmail.com

📞 +374 10 28 38 00

Principal Investigator

Julieta Hoveyan, MD

PRINCIPAL INVESTIGATOR

Immune Oncology Research Institute, Yerevan, Armenia

Frequently Asked Questions

Who can join the NCT05711992 clinical trial?

This trial is open to participants of all sexes, aged 1 Day or older, up to 25 Years, studying Embryonal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05711992 currently recruiting?

Yes, NCT05711992 is actively recruiting participants. Contact the research team at julia.hoveyan95@gmail.com for enrollment information.

Where is the NCT05711992 trial being conducted?

This trial is being conducted at Yerevan, Armenia, Ottawa, Canada, Budapest, Hungary, New Delhi, India and 7 additional locations.

Who is sponsoring the NCT05711992 clinical trial?

NCT05711992 is sponsored by Immune Oncology Research Institute. The principal investigator is Julieta Hoveyan, MD at Immune Oncology Research Institute, Yerevan, Armenia. The trial plans to enroll 300 participants.

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