- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gianpiero Tamburrini
- 전화번호: +393349468776
- 이메일: gianpiero.tamburrini@policlinicogemelli.it
연구 장소
-
-
Lazio
-
Rome, Lazio, 이탈리아, 00168
- Fondazione Policlinico Universitario "A. Gemelli", IRCCS - UOC Neurochirurgia Infantile
-
연락하다:
- GIANPIERO TAMBURRINI, MD
- 전화번호: 00393349468776
- 이메일: gianpiero.tamburrini@policlinicogemelli.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful establishment of patient-derived organoids (PDOs) from medulloblastoma surgical specimens
기간: Up to 24 months
|
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.
|
Up to 24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gianpiero Tamburrini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 27529
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .