- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04065204
Metabolomic Analysis of Body Fluid of Medulloblastoma in Children
19. september 2019 opdateret af: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Metabolomic Analysis of Body Fluid of Medulloblastoma in Children Based on New Mass Spectrometry and Its Application in Clinical Diagnosis and Recurrence Monitoring
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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Shanghai
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Shanghai, Shanghai, Kina, 200092
- The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tilbagevirkende kraft
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Metabolic marker(Uracil in Da)
Tidsramme: 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.
|
Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
|
|
Metabolic marker(4-Hydroxyproline in Da)
Tidsramme: 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.
|
Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
|
|
Metabolic marker(Creatine in Da)
Tidsramme: 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.
|
Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
|
|
Metabolic marker(Glutamic acid in Da)
Tidsramme: 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.
|
Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mawei D Jiang, MD, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2019
Primær færdiggørelse (Forventet)
1. juni 2022
Studieafslutning (Forventet)
1. juni 2022
Datoer for studieregistrering
Først indsendt
29. juli 2019
Først indsendt, der opfyldte QC-kriterier
20. august 2019
Først opslået (Faktiske)
22. august 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- XH-19-006
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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