Children's and Adolescents' Medulloblastoma Molecular Subgroups in China

NCT03288168 | Unknown

• 2 other identifiers: XH-17-014CNOG-MB001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Medulloblastoma, Childhood

Keywords

Observation; Molecular Subgroup; NanoString

Outcome Measures

Primary Outcomes (1)

• 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.

  Follow-up for final survival period till 31 December 2017 or last available contact, whichever occurred first

Secondary Outcomes (1)

• Event Free Survival

  Follow-up for none-recurrence survival (metastasis/relapse) period till 31 December 2017 or last available contact, whichever occurred first.

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Children's Neuro-Oncology Group (CNOG): collaborator

Study Sites (9)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Fuzhou General Hospital of Nanjing Military Region

Fuzhou, Fujian, 350100, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, 510510, China

Location

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200086, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Either paraffin embedded tissue block or frozen tissue

MeSH Terms

Conditions

Medulloblastoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jie MA, MD, Phd

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Pediatric Neurosurgery

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

CN (9)