Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, PrognosisNCT03631823
Gut Microbiota and Glioblastoma Multiforme Prognosis
An observational study of Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis, run by Huashan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
- What is being tested?
- Chemotherapy with temozolomide or no chemotherapy
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2018to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- The participants diagnosed with glioblastoma multiforme by immunohistochemistry and molecular (IDH1, 1p19q, TERT) diagnosis of WHO 2016 classification of Gliomas.
- The healthy volunteers.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
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.
Read the detailed 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.
- Conditions
- Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
- Being tested
- Chemotherapy with temozolomide or no chemotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy with temozolomide or no chemotherapyOther
This study is just an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Radio/Chemotherapy group | The participants in this group receive the concurren radio/chemotrherapy Receives: Other: Chemotherapy with temozolomide or no chemotherapy | |
| Radio/ without chemotherapy group | The participants in this group receive the radiotherapy but without chemotrherapy Receives: Other: Chemotherapy with temozolomide or no chemotherapy | |
| Healthy volunteer group | The volunteers for control group Receives: Other: Chemotherapy with temozolomide or no chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform
To analysis the distribution and components of gut microbiota before operation
Measured: 12 months
The perturbation of gut microbiota by temozolomide chemotherapy
To investigate the change of components of gut microbiota induced by chemotherapy
Measured: 15 months
Link the gut microbiota and prognosis of GBM
To explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Aug 2018 (estimated)
- Primary completion10 Aug 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, PrognosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jinsong Wu, Ph.D. & M.D, Study chair, Huashan HospitalWeifeng Shi, Ph.D., Principal investigator, Taishan Medical UniviersityYingchao Liu, Ph.D. & M.D, Study director, Shandong provincial hospirtal affiliated to Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631823
- Sponsor's protocol ID
- GBM2018-2020
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03631823
- Acronym / sponsor ID
- GBM2018-2020
- Conditions
- Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Study start
- 10 Aug 2018 (estimated)
- Primary completion
- 10 Aug 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radio/Chemotherapy group | – | Other: Chemotherapy with temozolomide or no chemotherapyThe participants in this group receive the concurren radio/chemotrherapy |
| Radio/ without chemotherapy group | – | Other: Chemotherapy with temozolomide or no chemotherapyThe participants in this group receive the radiotherapy but without chemotrherapy |
| Healthy volunteer group | – | Other: Chemotherapy with temozolomide or no chemotherapyThe volunteers for control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The participants diagnosed with glioblastoma multiforme by immunohistochemistry and molecular (IDH1, 1p19q, TERT) diagnosis of WHO 2016 classification of Gliomas.
- The healthy volunteers.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy with temozolomide or no chemotherapyThis study is just an observational study. | Other | Healthy volunteer group, Radio/ without chemotherapy group, Radio/Chemotherapy group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsong Wu, Ph.D. & M.D study chair
Huashan Hospital
Weifeng Shi, Ph.D. principal investigator
Taishan Medical Univiersity
Yingchao Liu, Ph.D. & M.D study director
Shandong provincial hospirtal affiliated to Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota, Glioblastoma Multiforme, Microglia, Tumor Related Macrophagocyte, Prognosis, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Wu, Ph.D. & M.D. (+86-52880000 ext. 7220, wjsongc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.