Gut Microbiota and Glioblastoma Multiforme Prognosis
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years - 75 Years |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03631823 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Huashan Hospital |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jinsong Wu, Ph.D. & M.DWeifeng Shi, Ph.D.Yingchao Liu, Ph.D. & M.D |
| Principal Investigator Affiliation | Huashan HospitalTaishan Medical UniviersityShandong provincial hospirtal affiliated to Shandong University |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Unknown status |
| Countries | |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Jinsong Wu, Ph.D. & M.D.
For additional contact information, you can also visit the trial on clinicaltrials.gov.
