Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT04065204
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Analysis of Body Fluid of Medulloblastoma in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008527', 'term': 'Medulloblastoma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2019-07-29', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic marker(Uracil in Da)', 'timeFrame': 'Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.', 'description': '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.'}, {'measure': 'Metabolic marker(4-Hydroxyproline in Da)', 'timeFrame': 'Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.', 'description': '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.'}, {'measure': 'Metabolic marker(Creatine in Da)', 'timeFrame': 'Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.', 'description': '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.'}, {'measure': 'Metabolic marker(Glutamic acid in Da)', 'timeFrame': 'Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric Medulloblastoma', 'Metabolomics', 'Radiation Therapy'], 'conditions': ['Pediatric Medulloblastoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The samples are previous biological sample database data;\n* Sample collection time was 2017.05-2019.05;\n* The patient's age is over 3 years old;\n* KPS score ≥50 at the first diagnosis;\n* The patient was a medulloblastoma patient who had received surgical treatment and had not received radiotherapy or chemotherapy before.\n\nExclusion Criteria:\n\n* Recurrent patients;\n* Patients suffered from other malignant tumors during radiotherapy;\n* The body fluid samples or related clinical data are not perfect;\n* Storage failure of body fluid samples such as lipid dissolution and hemolysis occurred."}, 'identificationModule': {'nctId': 'NCT04065204', 'briefTitle': 'Metabolomic Analysis of Body Fluid of Medulloblastoma in Children', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Metabolomic Analysis of Body Fluid of Medulloblastoma in Children Based on New Mass Spectrometry and Its Application in Clinical Diagnosis and Recurrence Monitoring', 'orgStudyIdInfo': {'id': 'XH-19-006'}}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Mawei D Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}