Malignant Central Nervous System NeoplasmNCT06117930
Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research
An observational study of Malignant Central Nervous System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study explores how microorganisms in the gut can affect the growth and progression of brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Central Nervous System Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 13 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.
Who may be able to join
- All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.
Who cannot join
- Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Alfredo Quinones-Hinojosa, M.D.
About this study
Official title: Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research
This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.
II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer.
III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy.
OUTLINE: This is an observational study.
Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository
Biological samples such as stool, urine, blood, saliva, and/or tissue will be collected for storage in the Tumor-Gut Axis Biorepository. Samples may be collected at any of the following time periods during study participation: before/after steroid therapy, before/after surgical intervention, before/after radiation therapy, and before/after chemotherapy.
Measured: Approximately 1 year, or until samples have been collected based on scheduled treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Feb 2024
- Primary completion13 Dec 2029 (estimated)
- Study completion13 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfredo Quinones-Hinojosa, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117930
- Sponsor's protocol ID
- MC230707
- Other IDs
- NCI-2023-04797, 23-001388
- Status last verified
- Feb 2026
- First submitted
- 31 Oct 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Human Brain-Gut Axis and Gut Microbiome In Patients With Brain Lesions - Repository for Neuroscience Research
- ClinicalTrials.gov ID
- NCT06117930
- Acronym / sponsor ID
- MC230707
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 13 Dec 2029 (estimated)
- Study completion
- 13 Dec 2029 (estimated)
- First posted
- 7 Nov 2023 (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.
This study explores how microorganisms in the gut can affect the growth and progression of brain tumors.
Detailed description
PRIMARY OBJECTIVES:
- To establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.
II. To use spatial transcriptome/proteomics/multi-omics coupled with microbiome data from various sources including brain tissue and stool samples to understand how microbiota could impact disease development, progression, and treatment response in patients with brain cancer.
III. To study the effect of microbiome and potential relationships and/or microbiome reconstruction to impact patient's clinical outcomes including chemo, radiation, immunotherapy and/or cellular therapy.
OUTLINE: This is an observational study.
Participants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants undergo blood, tissue, saliva, urine and stool sample collection and complete questionnaires on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.
Key inclusion criteria (1 listed)
- All patients undergoing resection for a tumor of the central nervous system and associated controls are eligible to participate in this study.
Key exclusion criteria (1 listed)
- Excluded samples will be from patients younger than 18 years old. There are no exclusions due to race/sex.
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository
Time frame: Approximately 1 year, or until samples have been collected based on scheduled treatment.
Biological samples such as stool, urine, blood, saliva, and/or tissue will be collected for storage in the Tumor-Gut Axis Biorepository. Samples may be collected at any of the following time periods during study participation: before/after steroid therapy, before/after surgical intervention, before/after radiation therapy, and before/after chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Alfredo Quinones-Hinojosa, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Central Nervous System Neoplasm, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the Mayo Clinic Florida Tumor-Gut Axis Biorepository (time frame: Approximately 1 year, or until samples have been collected based on scheduled treatment.). 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 5 Feb 2026.