Gut Microbiota and Glioblastoma Multiforme Prognosis

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

Official title:

Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03631823
• Other study ID #: GBM2018-2020
• Status: Not yet recruiting
• Start date: August 10, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2018
• Source: Huashan Hospital
• Contact: Jinsong Wu, Ph.D. & M.D.
• Phone: +86-52880000
• Email: wjsongc[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2020
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Chemotherapy with temozolomide or no chemotherapy
This study is just an observational study.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Shandong Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform	To analysis the distribution and components of gut microbiota before operation	12 months
Primary	The perturbation of gut microbiota by temozolomide chemotherapy	To investigate the change of components of gut microbiota induced by chemotherapy	15 months
Primary	Link the gut microbiota and prognosis of GBM	To explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process.	20 months