Clinical trial NCT04065204: Metabolomic Analysis of Body Fluid of Medulloblastoma in Children
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Medulloblastoma
Keywords: Pediatric Medulloblastoma
Metabolomics
Radiation Therapy
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic marker(Uracil in Da)
timeFrame: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
measure: Metabolic marker(4-Hydroxyproline in Da)
timeFrame: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
measure: Metabolic marker(Creatine in Da)
timeFrame: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
measure: Metabolic marker(Glutamic acid in Da)
timeFrame: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
name: Mawei D Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: