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Clinical Trials/NCT04065204
NCT04065204UnknownNot Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country100 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Metabolic marker(Uracil in Da)

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
3 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Metabolic marker(Uracil in Da)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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