Identification of New Gene Spliceosomes in Neuroblastoma

NCT06502210 | Recruiting

• 1 other identifier: LCYJ20242005
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neuroblastoma

Keywords

Neuroblastoma; gene

Outcome Measures

Primary Outcomes (2)

• The differential expression of tissue

  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.

  1 year

• Specific transcript variant

  The changes in tumor differentiation-related specific transcripts were found by comparing third-generation sequencing of neuroblastoma tissue sample cell lines.

  1 year

Study Arms (2)

neuroblastoma group

The resected tumor tissue of patients with neuroblastoma was taken by surgical operation as experimental group.

Procedure: Personalized surgical therapy of neuroblastoma

Normal tissue adjacent to the tumor group

The normal tissue adjacent to tumor of patients with neuroblastoma was taken by surgical operation as control group.

Interventions

Personalized surgical therapy of neuroblastoma PROCEDURE

If the size of the tumor tissue is too large, the doctor gives the patient chemotherapy and then performs surgery to remove the tumor. In this study, the genotypes of children with neuroblastoma are screened by using Deep Sequencing Technology and Third Generation Sequencing Technology, and the treatment will be performed according to different therapeutic modalities.

neuroblastoma group

Eligibility Criteria

• Age: 1 Day - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The sample is from patients with neuroblastoma who underwent laparoscopic/open neuroblastoma surgery at Nantong University Affiliated Hospital from 2024 to 2026. Children with neuroblastoma range in age from 0 to 14, regardless of gender. Preoperative imaging examinations indicate a patient with neuroblastoma. Before postoperative chemotherapy, the patient's physical strength is good. A 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Researchers take neuroblastoma tissue and normal tissue adjacent to the tumor.

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Wenliang Ge, archiater

  Nantong University Affiliated Hospital

  STUDY CHAIR

Central Study Contacts

Wenliang Ge, archiater

CONTACT

0086-13962854122; gewl@ntu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 16, 2024
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)