Clinical trial · Observational
Identification of New Gene Spliceosomes in Neuroblastoma
Identification of New Gene Spliceosomes in Neuroblastoma and Their Translational Application in Clinical Accurate Diagnosis and Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neuroblastoma is an early childhood embryonic malignancy that originates from neural crest cells. Neuroblastoma shows high heterogeneity in biological, morphological, genetic, and clinical features. At present, the main treatment methods for neuroblastoma are surgical treatment combined with chemotherapy after the operation and immunological therapy. However, clinical studies have found that 40%~50% of patients don't have good outcomes after postoperative chemotherapy. The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts by using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology. The main questions this study aims to answer are: \[Question 1\]This study will use Third Generation Sequencing technology to find specific transcript variants associated with cancer differentiation; \[Question 2\]This study will identify possible tissue differential expression by using the Deep Sequencing Technology. Participants will undergo surgery, during which doctors will remove tumor tissue and adjacent normal tissue. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group. In this study, the different genotypes of children with neuroblastoma are screened by Deep Sequencing Technology and Third Generation Sequencing Technology. And according to the difference in genotypes, doctors will treat children with neuroblastoma personally. This study hopes to find new single nucleotide polymorphism and therapeutic targets.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized surgical therapy of neuroblastoma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- neuroblastoma group
- description
- The resected tumor tissue of patients with neuroblastoma was taken by surgical operation as experimental group.
- interventionNames
- Procedure: Personalized surgical therapy of neuroblastoma
- label
- Normal tissue adjacent to the tumor group
- description
- The normal tissue adjacent to tumor of patients with neuroblastoma was taken by surgical operation as control group.
Primary outcomes (2)
- measure
- The differential expression of tissue
- timeFrame
- 1 year
- description
- The outcome measure is the change in tissue differential expression obtained by comparing the deep sequencing results of neuroblastoma tissue samples and normal tissue samples.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Children with neuroblastoma range in age from 0 to 14, regardless of gender; * Preoperative imaging examinations indicate patient with neuroblastoma; * Before postoperative chemotherapy, the patient's physical strength is good. At the same time, the results of white blood cells, neutrophils, hemoglobin, platelets, and other test indicators are all within normal range, which is in line with the treatment conditions of the relevant chemotherapy and immunotherapy; * Preoperative pathological examination of the patient reveals neuroblastoma; * Patients have no other history of malignant tumors; * Patients voluntarily participate and sign informed consent and can comply with the study visit plan and other protocol requirements. Exclusion Criteria: * Patients who are found to have distant metastasis or ascites on preoperative examination are excluded; * Patients with severe liver and kidney dysfunction, as well as those with autoimmune diseases are excluded; * Patients with severe cardiovascular disease who can not tolerate general anesthesia are excluded; * Patients who have other malignancies or blood disorders are excluded.
References
Publications (32)
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- BACKGROUNDLopez G, Conkrite KL, Doepner M, Rathi KS, Modi A, Vaksman Z, Farra LM, Hyson E, Noureddine M, Wei JS, Smith MA, Asgharzadeh S, Seeger RC, Khan J, Guidry Auvil J, Gerhard DS, Maris JM, Diskin SJ. Somatic structural variation targets neurodevelopmental genes and identifies SHANK2 as a tumor suppressor in neuroblastoma. Genome Res. 2020 Sep;30(9):1228-1242. doi: 10.1101/gr.252106.119. Epub 2020 Aug 13. PMID 32796005
- BACKGROUNDBrady SW, Liu Y, Ma X, Gout AM, Hagiwara K, Zhou X, Wang J, Macias M, Chen X, Easton J, Mulder HL, Rusch M, Wang L, Nakitandwe J, Lei S, Davis EM, Naranjo A, Cheng C, Maris JM, Downing JR, Cheung NV, Hogarty MD, Dyer MA, Zhang J. Pan-neuroblastoma analysis reveals age- and signature-associated driver alterations. Nat Commun. 2020 Oct 14;11(1):5183. doi: 10.1038/s41467-020-18987-4. PMID 33056981