Clinical Trials Directory

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UnknownNCT03631823

Gut Microbiota and Glioblastoma Multiforme Prognosis

Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme

Status
Unknown
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Huashan Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERChemotherapy with temozolomide or no chemotherapyThis study is just an observational study.

Timeline

Start date
2018-08-10
Primary completion
2019-08-10
Completion
2020-05-01
First posted
2018-08-15
Last updated
2018-08-15

Source: ClinicalTrials.gov record NCT03631823. Inclusion in this directory is not an endorsement.