Gut Microbiota and Glioblastoma Multiforme Prognosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-10

Study Completion Date

2020-05-01

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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Radio/Chemotherapy group

The participants in this group receive the concurren radio/chemotrherapy

Chemotherapy with temozolomide or no chemotherapy

Intervention Type OTHER

This study is just an observational study.

Radio/ without chemotherapy group

The participants in this group receive the radiotherapy but without chemotrherapy

Chemotherapy with temozolomide or no chemotherapy

Intervention Type OTHER

This study is just an observational study.

Healthy volunteer group

The volunteers for control group

Chemotherapy with temozolomide or no chemotherapy

Intervention Type OTHER

This study is just an observational study.

Interventions

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Chemotherapy with temozolomide or no chemotherapy

This study is just an observational study.

Intervention Type OTHER

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes