Gut Microbiota and Glioblastoma Multiforme Prognosis

Study Overview
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Brief Summary
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Glioma is the most common primary cancer of the central nervous system, and around 50% of patients present with the most aggressive form of the disease, glioblastoma. Conventional therapies, including surgery, radiotherapy, and pharmacotherapy (typically chemotherapy with temozolomide), have not resulted in major improvements in the survival outcomes with only a median survival of around 15 months.The main reason may be related to the highly immunosuppressive tumor microenvironment. In recent years, the microbiome has emerged as a key regulator of not only systemic immune regulation but brain circuitry, neuro-physiology and microglia development. We hypothesized that there is a link between the gut microbiota and the GBM development and evolution through the immune regulation cells (microglia and tumor related macrophagocyte) in the blood circulation to impact the prognosis( PFS and MST) of GBM patients.

Detailed Description
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We divide the paticipants into three groups. (total number = 200 subjects) Radio/Chemotherapy group - 80 subjects Radio/ without chemotherapy group - 70 subjects Healthy volunteer group - 50 subjects After the collection of stools before operation and 3 months after the operaton, we will analyze the composition and distribution of gut microbiota, and compare the results of three experiment groups.Then we will followe up the patients and analyze the correlation between gut microbiota and prognosis of GBM.

Official Title
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Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme

Conditions
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Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis

Intervention / Treatment
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* Other: Chemotherapy with temozolomide or no chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants diagnosed with glioblastoma multiforme by immunohistochemistry and molecular (IDH1, 1p19q, TERT) diagnosis of WHO 2016 classification of Gliomas. The healthy volunteers. Exclusion Criteria: No cancer or IBD (inflammatory bowel disease); No history of abdominal surgery; No medication related to gastrointestinal motility within 3 months; No oral antibiotic treatments previous 1 month before neurosurgery operation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radio/Chemotherapy group<br>The participants in this group receive the concurren radio/chemotrherapy | Other: Chemotherapy with temozolomide or no chemotherapy<br>* This study is just an observational study.<br>|
| Radio/ without chemotherapy group<br>The participants in this group receive the radiotherapy but without chemotrherapy | Other: Chemotherapy with temozolomide or no chemotherapy<br>* This study is just an observational study.<br>|
| Healthy volunteer group<br>The volunteers for control group | Other: Chemotherapy with temozolomide or no chemotherapy<br>* This study is just an observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform | To analysis the distribution and components of gut microbiota before operation | 12 months | 
| The perturbation of gut microbiota by temozolomide chemotherapy | To investigate the change of components of gut microbiota induced by chemotherapy | 15 months | 
| Link the gut microbiota and prognosis of GBM | To explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process. | 20 months |