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.
Full Title of Study: “Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: August 10, 2019
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.
- Other: Chemotherapy with temozolomide or no chemotherapy
- This study is just an observational study.
Arms, Groups and Cohorts
- Radio/Chemotherapy group
- The participants in this group receive the concurren radio/chemotrherapy
- Radio/ without chemotherapy group
- The participants in this group receive the radiotherapy but without chemotrherapy
- Healthy volunteer group
- The volunteers for control group
Clinical Trial Outcome Measures
- Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform
- Time Frame: 12 months
- To analysis the distribution and components of gut microbiota before operation
- The perturbation of gut microbiota by temozolomide chemotherapy
- Time Frame: 15 months
- To investigate the change of components of gut microbiota induced by chemotherapy
- Link the gut microbiota and prognosis of GBM
- Time Frame: 20 months
- To explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process.
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Huashan Hospital
- Shandong Provincial Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Jinsong Wu, Professor – Huashan Hospital
- Overall Official(s)
- Jinsong Wu, Ph.D. & M.D, Study Chair, Huashan Hospital
- Weifeng Shi, Ph.D., Principal Investigator, Taishan Medical Univiersity
- Yingchao Liu, Ph.D. & M.D, Study Director, Shandong provincial hospirtal affiliated to Shandong University
- Overall Contact(s)
- Jinsong Wu, Ph.D. & M.D., +86-52880000, firstname.lastname@example.org
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