Gut Microbiota and Glioblastoma Multiforme Prognosis

Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme

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.

Study Overview

• Status: Unknown
• Conditions: Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
• Intervention / Treatment: Other: Chemotherapy with temozolomide or no chemotherapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Jinsong Wu, Ph.D. & M.D.; Phone Number: 7220 +86-52880000; Email: wjsongc@126.com
• Study Contact Backup: Name: Yingchao Liu, Ph.D. & M.D; Phone Number: +8652880000 +86-68776128; Email: 13805311573@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radio/Chemotherapy group; The participants in this group receive the concurren radio/chemotrherapy	Other: Chemotherapy with temozolomide or no chemotherapy; This study is just an observational study.
Radio/ without chemotherapy group; The participants in this group receive the radiotherapy but without chemotrherapy	Other: Chemotherapy with temozolomide or no chemotherapy; This study is just an observational study.
Healthy volunteer group; The volunteers for control group	Other: Chemotherapy with temozolomide or no chemotherapy; This study is just an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform	To analysis the distribution and components of gut microbiota before operation	12 months
The perturbation of gut microbiota by temozolomide chemotherapy	To investigate the change of components of gut microbiota induced by chemotherapy	15 months
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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shandong Provincial Hospital
• Investigators: Principal Investigator: Weifeng Shi, Ph.D., Taishan Medical Univiersity; Study Director: Yingchao Liu, Ph.D. & M.D, Shandong provincial hospirtal affiliated to Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 10, 2018
• Primary Completion (ANTICIPATED): August 10, 2019
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: GBM2018-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No