- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07694622
Targeting MYC in High-Risk Medulloblastoma (MYCMB)
Exploiting High MYC Expression as a Potential Vulnerability for Treatment of High-Risk Medulloblastoma
Medulloblastoma is the most common malignant brain tumor in children. Group 3 medulloblastoma (G3 MB) represents the most aggressive molecular subtype and is associated with poor prognosis, particularly in cases characterized by high expression or amplification of the MYC oncogene. Current treatment strategies are not tailored to this subgroup and are associated with significant long-term toxicities, highlighting the need for more specific therapeutic approaches.
This study aims to characterize biological processes and molecular pathways driven by high MYC expression in high-risk G3 medulloblastoma in order to identify potential therapeutic vulnerabilities. The study will investigate MYC-associated regulation of gene expression and RNA splicing in tumor cells and will define molecular dependencies that may be targeted using candidate or repurposed anticancer agents.
To achieve this, publicly available genomic datasets will be analyzed, findings will be validated in patient tumor specimens, and patient-derived three-dimensional (3D) tumor models will be established from surgical samples. These models will be used for ex vivo assessment of selected therapeutic strategies in a system that preserves key features of the original tumor.
This translational approach integrates computational analyses, molecular validation, and functional testing in patient-derived models to improve understanding of MYC-associated tumor biology in Group 3 medulloblastoma.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Group 3 medulloblastoma (G3 MB) is the most aggressive molecular subgroup of medulloblastoma and is associated with poor prognosis, particularly in tumors characterized by MYC amplification or high MYC expression. Despite multimodal treatment including surgery, chemotherapy, and craniospinal irradiation, overall survival remains limited and survivors frequently experience significant long-term treatment-related toxicities. Given the largely undruggable nature of MYC, identifying MYC-dependent biological processes that can be therapeutically targeted represents an unmet clinical need.
This study investigates molecular mechanisms underlying MYC-driven tumor aggressiveness and aims to identify actionable vulnerabilities in high-risk G3 medulloblastoma. The project integrates retrospective molecular analyses, prospective collection of tumor specimens, transcriptomic data mining, and functional validation using patient-derived models.
Publicly available RNA sequencing datasets will be analyzed to compare tumors with high versus low MYC expression. Differential gene expression and alternative splicing analyses will be integrated with existing experimental datasets from MYC-depleted medulloblastoma models to identify MYC-regulated pathways and molecular processes.
Candidate genes and molecular signatures identified through bioinformatic analyses will be validated in retrospective tumor specimens using quantitative gene expression assays and evaluation of MYC-associated transcriptional and splicing programs.
In parallel, tumor samples collected from prospectively enrolled patients undergoing standard-of-care surgical resection will be used to establish patient-derived three-dimensional (3D) cultures. These models will be characterized histologically and molecularly to assess concordance with the corresponding primary tumors. Only models that retain key histological and genomic features will be used for downstream functional studies.
Patient-derived 3D cultures will be used as ex vivo platforms to evaluate therapeutic strategies targeting MYC-dependent pathways identified in molecular analyses. Selected compounds will be tested individually or in combination using assays measuring cell viability, proliferation, and survival.
This study does not involve investigational medicinal products or medical devices. All clinical procedures, including surgery and tissue collection, are performed according to standard clinical practice, without additional interventions for research purposes.
This translational project integrates computational analyses, molecular validation, and functional testing in patient-derived models to improve understanding of MYC-driven tumor biology in Group 3 medulloblastoma. The molecular insights generated may also be relevant to other pediatric and adult malignancies characterized by MYC dysregulation.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gianpiero Tamburrini
- Numéro de téléphone: +393349468776
- E-mail: gianpiero.tamburrini@policlinicogemelli.it
Lieux d'étude
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Lazio
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Rome, Lazio, Italie, 00168
- Fondazione Policlinico Universitario "A. Gemelli", IRCCS - UOC Neurochirurgia Infantile
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Contact:
- GIANPIERO TAMBURRINI, MD
- Numéro de téléphone: 00393349468776
- E-mail: gianpiero.tamburrini@policlinicogemelli.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients with histologically confirmed Group 3 medulloblastoma (G3 MB)
- Age between 0 and 20 years
- Undergoing surgical treatment at the UOC Child Neurosurgery Unit, Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Rome
- Availability of tumor tissue obtained during standard-of-care surgical resection for molecular analyses and/or establishment of patient-derived organoids
- Written informed consent provided by the patient and/or parent/legal guardian (prospective cohort)
- Inclusion of retrospective cases in accordance with applicable Italian privacy regulations (Art. 110-bis)
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Medulloblastoma tissue collection and ex vivo translational research
Participants with medulloblastoma undergoing standard-of-care surgical resection will be enrolled after informed consent.
Tumor tissue collected during surgery will be used to generate patient-derived organoids (PDOs) for ex vivo translational research.
Analyses will include molecular characterization, transcriptomic profiling, and evaluation of tumor cell responses to selected anticancer compounds in preclinical assays.
No investigational drugs or medical devices are administered to participants, and no additional clinical procedures beyond routine care are performed.
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Tumor tissue will be collected during standard-of-care surgical resection of medulloblastoma.
No additional surgical procedures will be performed for research purposes.
Collected tissue will be used for molecular analyses and the establishment of patient-derived three-dimensional (3D) cultures for ex vivo translational research, including characterization of MYC-associated molecular pathways and evaluation of tumor cell responses to selected compounds in preclinical assays.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Successful establishment of patient-derived organoids (PDOs) from medulloblastoma surgical specimens
Délai: Up to 24 months
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Rate of successful generation of patient-derived organoids (PDOs) from freshly resected high-risk Group 3 medulloblastoma surgical specimens.
Success will be defined by the ability of tumor samples to generate stable and expandable three-dimensional (3D) cultures in vitro.
Established models will be evaluated for histological and molecular concordance with the corresponding parental tumors using standard pathological and genetic analyses.
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Up to 24 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Gianpiero Tamburrini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 27529
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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