Identification of New Gene Spliceosomes in Neuroblastoma

July 12, 2024 updated by: Affiliated Hospital of Nantong University

Identification of New Gene Spliceosomes in Neuroblastoma and Their Translational Application in Clinical Accurate Diagnosis and Therapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology. This study hopes to find new single nucleotide polymorphism and therapeutic targets.

Firstly, researchers collect tumor tissues and adjacent normal tissues of 20 children with neuroblastoma meeting the inclusion criteria and collect their clinical data. 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.

Secondly, researchers will find differentially expressed genes using Deep Sequencing technology and Third Generation Sequencing Technology to sequence 7 neuroblastoma cell lines. The expression of the transcription isoforms was divided into one group of N-myc gene amplification and another group of N-myc gene non-amplification by using Third Generation Sequencing Technology. After extracting the total RNA from tissues, researchers check the RNA's purity, concentration, and integrity. If the RNA is tested up to standard, researchers will build a gene library. After the construction of the gene library is completed, researchers will use the machine to sequence tissues.

Finally, survival analysis and repeated measurements will be used to analyze the data of the experimental group and control group in this experiment. T-test will be used for measurement data. χ2 test will be used for counting data. Kaplan-Meier method and Cox regression analysis will be used for survival analysis. All statistical analyses will be performed using Statistical Analysis Software (Stata 26.0). P < 0.05 is considered significant.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenliang Ge, archiater
  • Phone Number: 0086-13962854122
  • Email: gewl@ntu.edu.cn

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • Wenliang Ge, archiater
          • Phone Number: 0086-13962854122
          • Email: gewl@ntu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neuroblastoma group
The resected tumor tissue of patients with neuroblastoma was taken by surgical operation as experimental group.
Procedure: Personalized surgical therapy of neuroblastoma
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differential expression of tissue
Time Frame: 1 year
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
Time Frame: 1 year
The changes in tumor differentiation-related specific transcripts were found by comparing third-generation sequencing of neuroblastoma tissue sample cell lines.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Chair: Wenliang Ge, archiater, Nantong University Affiliated Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

June 30, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCYJ20242005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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