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Gut Microbiota and Glioblastoma Multiforme Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 13, 2018
First Posted Date August 15, 2018
Last Update Posted Date August 15, 2018
Estimated Study Start Date August 10, 2018
Estimated Primary Completion Date August 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2018)
  • 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
  • The perturbation of gut microbiota by temozolomide chemotherapy [ Time Frame: 15 months ]
    To investigate the change of components of gut microbiota induced by chemotherapy
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gut Microbiota and Glioblastoma Multiforme Prognosis
Official Title Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
microbiota DNA are extracted from human feces.
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.
Condition Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
Intervention Other: Chemotherapy with temozolomide or no chemotherapy
This study is just an observational study.
Study Groups/Cohorts
  • Radio/Chemotherapy group
    The participants in this group receive the concurren radio/chemotrherapy
    Intervention: Other: Chemotherapy with temozolomide or no chemotherapy
  • Radio/ without chemotherapy group
    The participants in this group receive the radiotherapy but without chemotrherapy
    Intervention: Other: Chemotherapy with temozolomide or no chemotherapy
  • Healthy volunteer group
    The volunteers for control group
    Intervention: Other: Chemotherapy with temozolomide or no chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 13, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2020
Estimated Primary Completion Date August 10, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03631823
Other Study ID Numbers GBM2018-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jinsong Wu, Huashan Hospital
Study Sponsor Huashan Hospital
Collaborators Shandong Provincial Hospital
Investigators
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
PRS Account Huashan Hospital
Verification Date August 2018