- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05711992
Rare Embryonal Tumors of the Central Nervous System: International Registry
Study Overview
Status
Conditions
Detailed Description
CNS tumors are the most common solid malignancies and the leading cause of children's cancer-related mortality. Embryonal tumors account for approximately 20-25% of all primary CNS tumors in children. Although medulloblastomas are the most commonly diagnosed malignant brain tumors, other embryonal tumors are relatively rare. Several studies of rare embryonal tumors have been published, but the number of included patients is generally small. Diagnosis of different subtypes of rare embryonal tumors can be extremely challenging. Because of limited data, there are no standard treatment recommendations for patients with rare embryonal tumors.
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:
- Patient characteristics
- Characteristics of rare CNS embryonal tumors
- Details of the diagnosis and treatment
- Complications and late effects of treatment
- Outcomes
- Follow-up information
Quality control and data management will be conducted by the Immune Oncology Research Institute.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julieta Hoveyan, MD
- Phone Number: +374 10 28 38 00
- Email: julia.hoveyan95@gmail.com
Study Contact Backup
- Name: Ruzanna Papyan, MD
- Phone Number: +374 10 28 38 00
- Email: ruzannapapyan92@gmail.com
Study Locations
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Yerevan, Armenia, 0014
- Recruiting
- Hematology Center named after prof. R. Yeolyan
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Contact:
- Julieta Hoveyan, MD
- Phone Number: +374 10 28 38 00
- Email: julia.hoveyan95@gmail.com
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Contact:
- Ruzanna Papyan, MD
- Phone Number: +374 10 28 38 00
- Email: ruzannapapyan92@gmail.com
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Ottawa, Canada, K1H 8L1
- Recruiting
- Children's Hospital of Eastern Ontario (CHEO)
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Contact:
- Consolato M Sergi, MD, PhD, MPH
- Email: csergi@cheo.on.ca
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Budapest, Hungary, 1085
- Recruiting
- Semmelweis University
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Contact:
- Miklós Garami, MD, MSc, PhD
- Email: miklos.garami@gmail.com
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Contact:
- Edit Bruckner, MD
- Email: edit.brueckner@gmail.com
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New Delhi, India, 110029
- Recruiting
- National Cancer Institute, All India Institutes of Medical Sciences
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Contact:
- Supriya Mallick, MD
- Email: drsupriyamallick@gmail.com
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Contact:
- Akash Kumar, MD
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Tehran, Iran, Islamic Republic of, 16686 19551
- Recruiting
- Oncology Department of Golestan hospital
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Contact:
- Azim Mehrvar, MD
- Email: drazimmehrvar@yahoo.com
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Principal Investigator:
- Azim Mehrvar, MD
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Sub-Investigator:
- Maryam Tashvighi, MD
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Sub-Investigator:
- Narjes Mehrvar, PhD
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Rome, Italy, 00163
- Recruiting
- IRCCS Istituto Ospedale Pediatrico Bambino Gesù
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Contact:
- Angela Mastronuzzi, MD, PhD
- Email: angela.mastronuzzi@opbg.net
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Contact:
- Giada Del Baldo, MD
- Email: giada.delbaldo@opbg.net
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Guadalajara, Mexico, 44340
- Recruiting
- Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"
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Contact:
- Regina Mallinalli Navarro Martin Del Campo, MD
- Email: reginamallinalli@hotmail.com
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Mexico City, Mexico, 01120
- Recruiting
- Centro Médico ABC
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Contact:
- Alejandra Jimena García Velázquez, MD
- Email: ale.garciavelazquez@gmail.com
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Bellavista, Peru, 07011
- Recruiting
- Hospital Nacional Alberto Sabogal Sologuren - EsSalud
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Contact:
- Omar Reyes Cruzado, MD
- Email: omarreyescruzado@hotmail.com
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Contact:
- Sofia Aguilar Moreno, MD
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Lima, Peru, 15072
- Recruiting
- Hospital Nacional Edgardo Rebagliati Martins
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Contact:
- Ana Maria Glória Paredes Guerra, MD
- Email: gloriaparedes2000@yahoo.com
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Taichung, Taiwan, 40447
- Recruiting
- China Medical University Children's Hospital
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Contact:
- Su Min-Yu, MD
- Email: 035515@tool.caaumed.org.tw
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Contact:
- Ching-Tien Peng, MD
- Email: penect@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-year overall survival
Time Frame: 3 years
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3 years
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5-year overall survival
Time Frame: 5 years
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5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete remission rate
Time Frame: 5 years
|
5 years
|
3-year event-free survival
Time Frame: 3 years
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3 years
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5-year event-free survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Investigators
- Study Director: Gevorg Tamamyan, MD, PhD, DSc, Immune Oncology Research Institute, Yerevan, Armenia
- Principal Investigator: Julieta Hoveyan, MD, Immune Oncology Research Institute, Yerevan, Armenia
- Principal Investigator: Ruzanna Papyan, MD, Immune Oncology Research Institute, Yerevan, Armenia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMMONC0005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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