Gut Microbiota and Glioblastoma Multiforme Prognosis

• Conditions: Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
• Interventions: Other: Chemotherapy with temozolomide or no chemotherapy

• Registration Number: NCT03631823
• Lead Sponsor: Huashan Hospital

Brief Summary

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

We divide the paticipants into three groups. (total number = 200 subjects)

1. Radio/Chemotherapy group - 80 subjects

2. Radio/ without chemotherapy group - 70 subjects

3. 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.

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08-10
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2019-08-10
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

1. No cancer or IBD (inflammatory bowel disease);
2. No history of abdominal surgery;
3. No medication related to gastrointestinal motility within 3 months;
4. No oral antibiotic treatments previous 1 month before neurosurgery operation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteer group	Chemotherapy with temozolomide or no chemotherapy	The volunteers for control group
Radio/Chemotherapy group	Chemotherapy with temozolomide or no chemotherapy	The participants in this group receive the concurren radio/chemotrherapy
Radio/ without chemotherapy group	Chemotherapy with temozolomide or no chemotherapy	The participants in this group receive the radiotherapy but without chemotrherapy

Primary Outcome Measures

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