Metabolomic Analysis of Body Fluid of Medulloblastoma in Children

• Conditions: Pediatric Medulloblastoma

• Registration Number: NCT04065204
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic marker(Uracil in Da)	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.	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.
Metabolic marker(4-Hydroxyproline in Da)	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.	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.
Metabolic marker(Glutamic acid in Da)	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.	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.
Metabolic marker(Creatine in Da)	Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.	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.

Trial Locations

Locations (1)

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China