Clinical trial NCT03631823: Gut Microbiota and Glioblastoma Multiforme Prognosis
Official title: Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2018-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients enrolled from neurosurgery department of Huashan hospital and the Shandong provincial hospital affiliated to Shandong University; while the healthy volunteers come from the health examination center of huashan hospital and Shandong provincial hospital affiliated to Shandong University.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform
timeFrame: 12 months
measure: The perturbation of gut microbiota by temozolomide chemotherapy
timeFrame: 15 months
measure: Link the gut microbiota and prognosis of GBM
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Jinsong Wu, Ph.D. & M.D
role: STUDY_CHAIR
affiliation: Taishan Medical Univiersity
name: Weifeng Shi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong provincial hospirtal affiliated to Shandong University
name: Yingchao Liu, Ph.D. & M.D
role: STUDY_DIRECTOR
References: