Gut Microbiota and Glioblastoma Multiforme Prognosis

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

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.

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