Metabolomic Analysis of Body Fluid of Medulloblastoma in Children

Pediatric Medulloblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04065204
• Other study ID #: XH-19-006
• Status: Enrolling by invitation
• Start date: June 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medulloblastoma
• Pediatric Medulloblastoma

Locations

Country	Name	City	State
China	The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.