Gut Microbiota and Glioblastoma Multiforme Prognosis

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Fudan University

Status

Unknown

Conditions

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

Treatments

Other: Chemotherapy with temozolomide or no chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT03631823
GBM2018-2020

Details and patient eligibility

About

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.

Full description

We divide the paticipants into three groups. (total number = 200 subjects) Radio/Chemotherapy group - 80 subjects Radio/ without chemotherapy group - 70 subjects 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

  • No cancer or IBD (inflammatory bowel disease);
  • No history of abdominal surgery;
  • No medication related to gastrointestinal motility within 3 months;
  • No oral antibiotic treatments previous 1 month before neurosurgery operation.

Trial design

200 participants in 3 patient groups

Radio/Chemotherapy group
Description:
The participants in this group receive the concurren radio/chemotrherapy
Treatment:
Other: Chemotherapy with temozolomide or no chemotherapy
Radio/ without chemotherapy group
Description:
The participants in this group receive the radiotherapy but without chemotrherapy
Treatment:
Other: Chemotherapy with temozolomide or no chemotherapy
Healthy volunteer group
Description:
The volunteers for control group
Treatment:
Other: Chemotherapy with temozolomide or no chemotherapy

Trial contacts and locations

0

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Central trial contact

Yingchao Liu, Ph.D. & M.D; Jinsong Wu, Ph.D. & M.D.

Data sourced from clinicaltrials.gov

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