Medulloblastoma, ChildhoodNCT05406947
Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children
An observational study of Medulloblastoma, Childhood, run by Beijing Tiantan Hospital.
Trial summary
The purpose of this study:(1) Development of a new risk classification model for childhood medulloblastoma. (2) Evaluation and improvement of existing individualized treatment protocols. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Medulloblastoma, Childhood
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2023to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 350 medulloblastoma patients aged 0.5-18 years (except newborns)
Who may be able to join
- Age 0.5-18 years (except neonates).
- Pathologically confirmed medulloblastoma.
- Not having received any other relevant treatment before surgery.
- Completion of enhanced MRI of the head and spinal cord.
- Availability of tumor samples and determination of molecular typing.
- Postoperative KPS score ≥ 70.
- Voluntary enrollment in the group and the ability to receive long-term follow-up.
- The patient or the patient's family voluntarily signed the informed consent form.
Who cannot join
- Patients who have recently received other drugs or radiation therapy.
- Patients suffering from acute or chronic infectious diseases
- Patients suffering from neurological or psychiatric diseases or mental disorders that cannot be easily controlled, or poor compliance.
- Patients who cannot receive enhanced MRI scans.
- Other conditions that the investigator believes make the patient unfit to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study:(1) Development of a new risk classification model for childhood medulloblastoma. (2) Evaluation and improvement of existing individualized treatment protocols.
Read the detailed description
Medulloblastoma (medulloblastoma, MB) is the most common intracranial malignant tumor in children, accounting for 20% of all central nervous system tumors in children, seriously affecting the quality of life and life span of children. Based on a retrospective analysis of previous MB cases in our center, we found that the clinical prognosis of previous MB patients in our center was worse than that in foreign countries, with an overall five-year survival rate of about 65%, and nearly 30% of the patients had tumor recurrence and metastasis within 2 years after the operation, and the prognosis was poor. We analyzed the possible reasons as follows: (1) the compliance to radiotherapy and chemotherapy in children with MB in our center was poor, and some of the patients only completed radiotherapy and had poor compliance with chemotherapy; (2) due to the lack of family doctor system, the tumor of the newly diagnosed patients was huge, which seriously affected the important brain function and clinical prognosis; (3) the patients were not followed up strictly and regularly after operation to monitor tumor recurrence, which led to poor treatment effect after recurrence.
(4) the unified treatment standard has not been formed yet, and the treatment mode for patients is complex.
As the largest neurosurgery and pediatric neurosurgery center in China, the center intends to prospectively establish a high-quality homogeneous MB observation cohort in children, make use of the center's case resources and biological sample processing advantages, and carry out accurate treatment research on children's MB through regular follow-up and systematic management of the clinical cohort.
- Conditions
- Medulloblastoma, Childhood
- Being tested
- Prospective observational study, no intervention
- Keywords
- Medulloblastoma, Glioma, Medulloblastoma, Childhood, Recurrent, Neuroepithelioma
- Medical subject headings
- Medulloblastoma, Glioma, Recurrence, Neuroectodermal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective observational study, no interventionOther
Prospective observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into low risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. Receives: Other: Prospective observational study, no intervention | |
| Middle risk group | Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into middle risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. Receives: Other: Prospective observational study, no intervention | |
| High risk group | Based on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into high risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. Receives: Other: Prospective observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular typing
Medulloblastoma can be classified into four molecular types: WNT, SHH, G3 and G4.
Measured: 2022-2030
Overall survival
the time from operation to death
Measured: 2022-2030
Progression free survival
The time from operation to disease progression
Measured: 2022-2030
Quality of life scale
A scale for evaluating the quality of life of patients after operation
Measured: 2022-2030
Adjunctive treatment
Patients receive postoperative radiotherapy or chemotherapy
Measured: 2022-2030
Secondary outcomes (2)
Age at diagnosis
Measured: 2022-2030
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 2022-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start30 Jan 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medulloblastoma, ChildhoodStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Children's Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Peking University Third Hospital
- Responsible party
- Principal investigator, Tianyongji, Beijing Tiantan Hospital
- Investigators
- Yongji Tian, MD, Principal investigator, Beijing TianTanHospital, China Capital Medical UniversityFU ZHAO, MD, Principal investigator, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406947
- Sponsor's protocol ID
- ChiCTR2200058760
- Status last verified
- Feb 2023
- First submitted
- 1 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children
- ClinicalTrials.gov ID
- NCT05406947
- Acronym / sponsor ID
- ChiCTR2200058760
- Conditions
- Medulloblastoma, Childhood
- Keywords
- Medulloblastoma, Glioma, Medulloblastoma, Childhood, Recurrent, Neuroepithelioma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Children's Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Peking University Third Hospital
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jun 2022 (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.
The purpose of this study:(1) Development of a new risk classification model for childhood medulloblastoma. (2) Evaluation and improvement of existing individualized treatment protocols.
Detailed description
Medulloblastoma (medulloblastoma, MB) is the most common intracranial malignant tumor in children, accounting for 20% of all central nervous system tumors in children, seriously affecting the quality of life and life span of children. Based on a retrospective analysis of previous MB cases in our center, we found that the clinical prognosis of previous MB patients in our center was worse than that in foreign countries, with an overall five-year survival rate of about 65%, and nearly 30% of the patients had tumor recurrence and metastasis within 2 years after the operation, and the prognosis was poor. We analyzed the possible reasons as follows: (1) the compliance to radiotherapy and chemotherapy in children with MB in our center was poor, and some of the patients only completed radiotherapy and had poor compliance with chemotherapy; (2) due to the lack of family doctor system, the tumor of the newly diagnosed patients was huge, which seriously affected the important brain function and clinical prognosis; (3) the patients were not followed up strictly and regularly after operation to monitor tumor recurrence, which led to poor treatment effect after recurrence.
(4) the unified treatment standard has not been formed yet, and the treatment mode for patients is complex.
As the largest neurosurgery and pediatric neurosurgery center in China, the center intends to prospectively establish a high-quality homogeneous MB observation cohort in children, make use of the center's case resources and biological sample processing advantages, and carry out accurate treatment research on children's MB through regular follow-up and systematic management of the clinical cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk group | – | Other: Prospective observational study, no interventionBased on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into low risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. |
| Middle risk group | – | Other: Prospective observational study, no interventionBased on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into middle risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. |
| High risk group | – | Other: Prospective observational study, no interventionBased on clinicopathological diagnosis and molecular pathological diagnosis, the children were classified into high risk groups, individualized radiotherapy and chemotherapy plan was made, and a perfect registration and follow-up system was established. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 350 medulloblastoma patients aged 0.5-18 years (except newborns)
Key inclusion criteria (8 listed)
- Age 0.5-18 years (except neonates).
- Pathologically confirmed medulloblastoma.
- Not having received any other relevant treatment before surgery.
- Completion of enhanced MRI of the head and spinal cord.
- Availability of tumor samples and determination of molecular typing.
Key exclusion criteria (5 listed)
- Patients who have recently received other drugs or radiation therapy.
- Patients suffering from acute or chronic infectious diseases
- Patients suffering from neurological or psychiatric diseases or mental disorders that cannot be easily controlled, or poor compliance.
- Patients who cannot receive enhanced MRI scans.
- Other conditions that the investigator believes make the patient unfit to participate in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective observational study, no interventionProspective observational study, no intervention | Other | High risk group, Low risk group, Middle risk group |
Primary outcome
Molecular typing
Time frame: 2022-2030
Medulloblastoma can be classified into four molecular types: WNT, SHH, G3 and G4.
Overall survival
Time frame: 2022-2030
the time from operation to death
Progression free survival
Time frame: 2022-2030
The time from operation to disease progression
Quality of life scale
Time frame: 2022-2030
A scale for evaluating the quality of life of patients after operation
Adjunctive treatment
Time frame: 2022-2030
Patients receive postoperative radiotherapy or chemotherapy
2 secondary outcomes
Age at diagnosis
Time frame: 2022-2030
BMI
Time frame: 2022-2030
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Yongji Tian, MD principal investigator
Beijing TianTanHospital, China Capital Medical University
FU ZHAO, MD principal investigator
Beijing Neurosurgical Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Medulloblastoma, Childhood, run by Beijing Tiantan Hospital.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yongji TIAN, MD (15801593549, tianyongji@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular typing (time frame: 2022-2030). The study lists 5 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 8 Feb 2023.