Pediatric MedulloblastomaNCT04065204
Metabolomic Analysis of Body Fluid of Medulloblastoma in Children
An observational study of Pediatric Medulloblastoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Pediatric Medulloblastoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
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
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.
Read the 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.
- Conditions
- Pediatric Medulloblastoma
- Keywords
- Pediatric Medulloblastoma, Metabolomics, Radiation Therapy
- Medical subject headings
- Medulloblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic marker(Uracil in Da)
- 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.
Measured: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(4-Hydroxyproline in Da)
- 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.
Measured: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(Creatine in Da)
- 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.
Measured: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Metabolic marker(Glutamic acid in Da)
- 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.
Measured: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric MedulloblastomaStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mawei D Jiang, MD, Principal investigator, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065204
- Sponsor's protocol ID
- XH-19-006
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04065204
- Acronym / sponsor ID
- XH-19-006
- Conditions
- Pediatric Medulloblastoma
- Keywords
- Pediatric Medulloblastoma, Metabolomics, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Different body fluid samples (blood,urine)of patients in each group are estimated to be 100 cases.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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(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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mawei D Jiang, MD principal investigator
Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Medulloblastoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic marker(Uracil in Da) (time frame: Changes of expression profiles of specific metabolic markers before and after radiotherapy,up to 3 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.