Skip to content

Gut Microbiota and Glioblastoma Multiforme Prognosis

Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03631823
Enrollment
200
Registered
2018-08-15
Start date
2018-08-10
Completion date
2020-05-01
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERChemotherapy with temozolomide or no chemotherapy

This study is just an observational study.

Sponsors

Shandong Provincial Hospital
CollaboratorOTHER_GOV
Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform12 monthsTo analysis the distribution and components of gut microbiota before operation
The perturbation of gut microbiota by temozolomide chemotherapy15 monthsTo investigate the change of components of gut microbiota induced by chemotherapy
Link the gut microbiota and prognosis of GBM20 monthsTo explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process.

Contacts

Primary ContactJinsong Wu, Ph.D. & M.D.
wjsongc@126.com+86-52880000
Backup ContactYingchao Liu, Ph.D. & M.D
13805311573@126.com+86-68776128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026