Metabolomic Analysis of Body Fluid of Medulloblastoma in Children

Metabolomic Analysis of Body Fluid of Medulloblastoma in Children Based on New Mass Spectrometry and Its Application in Clinical Diagnosis and Recurrence Monitoring

Based on a new mass spectrometry system, body fluid samples were analyzed to verify the role of metabolite analysis in the diagnosis of pediatric medulloblastoma.

Study Overview

• Status: Unknown
• Conditions: Pediatric Medulloblastoma

Detailed Description

Screening specific molecular metabolic markers for medulloblastoma after radiotherapy can improve the prediction of clinical diagnosis and prognosis of patients.The purpose of this study is to validate the role of metabolite analysis in the diagnosis of pediatric medulloblastoma based on the analysis of body fluid samples by a new mass spectrometry system.Based on the metabolic markers found by screening, the pathogenic mechanism of metabolic pathway blockade was explained, and the scientific basis for later treatment was put forward.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.

Description

Inclusion Criteria:

• The samples are previous biological sample database data;
• Sample collection time was 2017.05-2019.05;
• The patient's age is over 3 years old;
• KPS score ≥50 at the first diagnosis;
• The patient was a medulloblastoma patient who had received surgical treatment and had not received radiotherapy or chemotherapy before.

Exclusion Criteria:

• Recurrent patients;
• Patients suffered from other malignant tumors during radiotherapy;
• The body fluid samples or related clinical data are not perfect;
• Storage failure of body fluid samples such as lipid dissolution and hemolysis occurred.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic marker(Uracil in Da)	1. By comparing the expression of small molecule metabolites in body fluids between normal control group and patients with medulloblastoma before radiotherapy, to find specific markers. 2. To evaluate the expression of this metabolic marker in medulloblastoma patients before and after radiotherapy.	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(4-Hydroxyproline in Da)	1. By comparing the expression of small molecule metabolites in body fluids between normal control group and patients with medulloblastoma before radiotherapy, to find specific markers. 2. To evaluate the expression of this metabolic marker in medulloblastoma patients before and after radiotherapy.	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(Creatine in Da)	1. By comparing the expression of small molecule metabolites in body fluids between normal control group and patients with medulloblastoma before radiotherapy, to find specific markers. 2. To evaluate the expression of this metabolic marker in medulloblastoma patients before and after radiotherapy.	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(Glutamic acid in Da)	1. By comparing the expression of small molecule metabolites in body fluids between normal control group and patients with medulloblastoma before radiotherapy, to find specific markers. 2. To evaluate the expression of this metabolic marker in medulloblastoma patients before and after radiotherapy.	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Mawei D Jiang, MD, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Metabolomics; Radiation Therapy; Pediatric Medulloblastoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Medulloblastoma
• Other Study ID Numbers: XH-19-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes