Medulloblastoma, ChildhoodCNOG-MB001NCT03288168
Children's and Adolescents' Medulloblastoma Molecular Subgroups in China
An observational study of Medulloblastoma, Childhood, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 9 sites in China.
Trial summary
Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto an ever important position. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Medulloblastoma, Childhood
- How many people
- 200 participants
- Where
- 9 sitesChina
- Study dates
- 1 Sep 2017to 30 Jun 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents from 0-18 y/o, diagnosed with Medulloblastoma in CNOG-MB001 study participated institutions in mainland China, with available detailed clinical records, full followup records and available tumor samples, fitting eligibility criteria, are enrolled in this study.
Who may be able to join
- Participants must have classical histology posterior fossa medulloblastoma as determined by institutional neuro-pathological evaluation.
- Participants must have tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for NanoString test for distinguishing the molecular subgroups of medulloblastoma in Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine (SHXH).
- Participants must provide tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for immunohistochemistry assessment in verifying the molecular subgroups of medulloblastoma, or conduct the same immunohistochemistry test according to central analysis in SHXH, and send the slides to SHXH for center reviewing.
- Diagnostic imaging (pre and post operation (OP) contrast MRI or CT, Post-OP imaging conducted within 72 hours, no later than 14 days) must be forwarded to SHXH for central review to confirm eligibility.
- Sufficient pathologic material must be available for central analysis and review in SHXH.
- The patients must have no previous radiotherapy or chemotherapy other than corticosteroids.
- Ability to understand and willingness to comply with follow-up visits.
- Life expectancy more than 4 weeks.
Who cannot join
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.
- Tumor tissue sample not available for biological studies (from the initial diagnosis and/or relapse).
- Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate standard treatment or would likely interfere with study results.
- Patients obtained no radiation and/or chemo therapies are not excluded in this study since the nature history of the disease will also be evaluated.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, 350100
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangdong 999 Brain Hospital
Guangzhou, Guangdong, 510510
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200086
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Multi-center Retrospective Study on Clinical Features and Molecular Subgroups of Children and Adolescents With Medulloblastoma in China
Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto an ever important position. Reports and studies revealed highly correlated connection between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG) has launched many new studies on molecular subgroups-based specific treatment trails. In China, children and adolescents with brain tumor have been treated variously for a long time in lack of standardized comprehensive treatments. Same poor situation in basic research and clinical studies makes the Chinese children with brain tumor hardly catch up with international level in molecular diagnosis and specific treatments. There are limited studies, which were conducted by immunohistochemistry for identifying medulloblastoma molecular subgroups, indicating the similar correlation of the subgroups and outcomes to world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in May 2017, it makes studies from multiple centers in children's brain tumors become practical. And the availability of DNA methylation array, NanoString and other methods in medulloblastoma subgroup identification assures the quality of the method for this study.
Read the detailed description
Studies discovered that medulloblastoma is a group of tumors with different pathogenesis through different pathways, and majorly can be divided into four molecular subgroups. Moreover, multicenter retrospective studies from US, Canada and European Countries revealed that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor for the patient outcomes. This finding made WHO classification of tumours of central nervous system consider the markers in molecular pathway be an ever important indicator in the new diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA methylation arrays or other molecular methods makes subgroup identification more reliable. In China, there are limited single institutional studies, which were all conducted by immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of medulloblastoma, especially in pediatric patients. This multicenter retrospective study enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member institutions across the country, with available paraffin embedded samples and reliable follow-up information, to assess the correlation of molecular subgroups of medulloblastoma and outcomes in Chinese population.
This multicenter study recruits eligible patients from CNOG member institutions. Data validation and verification is double conducted by each center and investigators in central data base. Case report form (CRF) was designed by principle investigator and will be modified in the period of uploading first 5 cases by each participated center. The estimated enrollment is 200 cases after sample size assessment. Descriptive statistical analysis, Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square test will be used to validate the test efficiency of immunohistochemistry and NanoString methods.
- Conditions
- Medulloblastoma, Childhood
- Keywords
- Observation, Molecular Subgroup, NanoString
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 0-18 y/o Patients with Medulloblastoma | Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
Measured: Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first
Secondary outcomes (1)
Event Free Survival
The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
Measured: Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Neuro-Oncology Group (CNOG)
- Responsible party
- Principal investigator, Jie Ma, MD, PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jie MA, MD, Phd, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288168
- Sponsor's protocol ID
- XH-17-014
- Other IDs
- CNOG-MB001
- Acronym
- CNOG-MB001
- Status last verified
- Apr 2020
- First submitted
- 15 Sep 2017
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Retrospective Study on Clinical Features and Molecular Subgroups of Children and Adolescents With Medulloblastoma in China
- ClinicalTrials.gov ID
- NCT03288168
- Acronym / sponsor ID
- CNOG-MB001 / XH-17-014
- Conditions
- Medulloblastoma, Childhood
- Keywords
- Observation, Molecular Subgroup, NanoString
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Children's Neuro-Oncology Group (CNOG)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 Sep 2017 (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.
Recently, diagnosis and treatments for medulloblastoma becomes more complicated than before since the new World Health Organization (WHO) diagnosis criteria has put molecular marker onto an ever important position. Reports and studies revealed highly correlated connection between subgroups of medulloblastoma and patient outcomes. Children's Oncology Group (COG) has launched many new studies on molecular subgroups-based specific treatment trails. In China, children and adolescents with brain tumor have been treated variously for a long time in lack of standardized comprehensive treatments. Same poor situation in basic research and clinical studies makes the Chinese children with brain tumor hardly catch up with international level in molecular diagnosis and specific treatments. There are limited studies, which were conducted by immunohistochemistry for identifying medulloblastoma molecular subgroups, indicating the similar correlation of the subgroups and outcomes to world-wide reports. As the Children's Neuro-Oncology Group (CNOG) was established in China in May 2017, it makes studies from multiple centers in children's brain tumors become practical. And the availability of DNA methylation array, NanoString and other methods in medulloblastoma subgroup identification assures the quality of the method for this study.
Detailed description
Studies discovered that medulloblastoma is a group of tumors with different pathogenesis through different pathways, and majorly can be divided into four molecular subgroups. Moreover, multicenter retrospective studies from US, Canada and European Countries revealed that the molecular subgroup of medulloblastoma becomes an independent correlated risk factor for the patient outcomes. This finding made WHO classification of tumours of central nervous system consider the markers in molecular pathway be an ever important indicator in the new diagnosis criteria. In COG prospective studies for target therapies, subgroup distinguishing becomes indispensable, and the use of immunohistochemistry combined with NanoString, DNA methylation arrays or other molecular methods makes subgroup identification more reliable. In China, there are limited single institutional studies, which were all conducted by immunohistochemistry or polymerase chain reaction (PCR), on molecular sub-grouping of medulloblastoma, especially in pediatric patients. This multicenter retrospective study enrolls children and adolescents (0-18y/o) with primary medulloblastoma from CNOG member institutions across the country, with available paraffin embedded samples and reliable follow-up information, to assess the correlation of molecular subgroups of medulloblastoma and outcomes in Chinese population.
This multicenter study recruits eligible patients from CNOG member institutions. Data validation and verification is double conducted by each center and investigators in central data base. Case report form (CRF) was designed by principle investigator and will be modified in the period of uploading first 5 cases by each participated center. The estimated enrollment is 200 cases after sample size assessment. Descriptive statistical analysis, Two-Sample (Independent group) T-Test and one-way ANOVA will be used in epidemiological analysis. Cox-regression / Kaplan-Meier plot will be used in survival analysis. Chi-square test will be used to validate the test efficiency of immunohistochemistry and NanoString methods.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0-18 y/o Patients with Medulloblastoma | – | –Patients treated with comprehensive treatments including surgery, chemo-therapy with / without (less than 3 y/o) radiation, during the period of Jan 2008 and Dec 2012, whose tumor samples will be tested by NanoString and Histochemistry methods, are enrolled in this cohort group. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents from 0-18 y/o, diagnosed with Medulloblastoma in CNOG-MB001 study participated institutions in mainland China, with available detailed clinical records, full followup records and available tumor samples, fitting eligibility criteria, are enrolled in this study.
Key inclusion criteria (8 listed)
- Participants must have classical histology posterior fossa medulloblastoma as determined by institutional neuro-pathological evaluation.
- Participants must have tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for NanoString test for distinguishing the molecular subgroups of medulloblastoma in Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine (SHXH).
- Participants must provide tumor tissue samples (either paraffin embedded tissue block or frozen tissue) for immunohistochemistry assessment in verifying the molecular subgroups of medulloblastoma, or conduct the same immunohistochemistry test according to central analysis in SHXH, and send the slides to SHXH for center reviewing.
- Diagnostic imaging (pre and post operation (OP) contrast MRI or CT, Post-OP imaging conducted within 72 hours, no later than 14 days) must be forwarded to SHXH for central review to confirm eligibility.
- Sufficient pathologic material must be available for central analysis and review in SHXH.
Key exclusion criteria (4 listed)
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.
- Tumor tissue sample not available for biological studies (from the initial diagnosis and/or relapse).
- Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate standard treatment or would likely interfere with study results.
- Patients obtained no radiation and/or chemo therapies are not excluded in this study since the nature history of the disease will also be evaluated.
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
Overall Survival
Time frame: Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first
The observation period of outcome started with the first medical record available on site till last contact available on site or the end of the observation period (31 December 2017), whichever occurred first.
1 secondary outcome
Event Free Survival
Time frame: Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- 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. This study is not recruiting at the moment.
Jie MA, MD, Phd study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medulloblastoma, Childhood, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 9 sites 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 8 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Overall Survival (time frame: Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first). 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 17 Apr 2020.