Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| OTHER | Chemotherapy with temozolomide or no chemotherapy | This 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.