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Gut Microbiota and Glioblastoma Multiforme Prognosis

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ClinicalTrials.gov Identifier: NCT03631823
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Shandong Provincial Hospital
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital

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.

Condition or disease Intervention/treatment
Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
Estimated Study Start Date : August 10, 2018
Estimated Primary Completion Date : August 10, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. The perturbation of gut microbiota by temozolomide chemotherapy [ Time Frame: 15 months ]
    To investigate the change of components of gut microbiota induced by chemotherapy

  3. 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.


Biospecimen Retention:   Samples With DNA
microbiota DNA are extracted from human feces.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631823


Contacts
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Contact: Jinsong Wu, Ph.D. & M.D. +86-52880000 ext 7220 wjsongc@126.com
Contact: Yingchao Liu, Ph.D. & M.D +86-68776128 ext +8652880000 13805311573@126.com

Sponsors and Collaborators
Huashan Hospital
Shandong Provincial Hospital
Investigators
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Study Chair: Jinsong Wu, Ph.D. & M.D Huashan Hospital
Principal Investigator: Weifeng Shi, Ph.D. Taishan Medical Univiersity
Study Director: Yingchao Liu, Ph.D. & M.D Shandong provincial hospirtal affiliated to Shandong University

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Responsible Party: Jinsong Wu, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03631823     History of Changes
Other Study ID Numbers: GBM2018-2020
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents