Carotid Artery StenosisDT-MiNiNCT05968053
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
An observational study of Carotid Artery Stenosis and Glioma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids. Neurosurgery is the only department that can open the skull. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis, Glioma, Intracranial Aneurysm
- What is being tested?
- biological samples analysis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2023to 31 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included patients age 18-80 years with any types of neurosurgery Excluded patients refuse to participate
Who may be able to join
- Age 18-80 years
- Any type of neurosurgery
Who cannot join
- ·refusal of the patient to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Fa Lin, MD, 13681107240, 13681107240@163.com
About this study
Official title: Presence of Microplastics and Nanoplastics in Neurosurgery Patients
Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.
Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.
The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.
- Conditions
- Carotid Artery Stenosis, Glioma, Intracranial Aneurysm, Intracranial Hemorrhages, Brain Tumor
- Being tested
- biological samples analysis
- Keywords
- microplastics, nanoplastics, Intracranial Aneurysm, brain tumor, Carotid Artery Stenosis
- Medical subject headings
- Carotid Stenosis, Glioma, Intracranial Aneurysm, Intracranial Hemorrhages, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples analysisDiagnostic test
biological samples analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
microplastics
Detection of microplastics in human brain tissue and the blood undergoing neurosurgery
Measured: baseline, intraoperative
nanoplastics
Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery
Measured: baseline, intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolin Chen, MD, Beijing Tiantan Hospital
- Investigators
- Runting Li, MD, Principal investigator, Beijing Tiantan HospitalYitong Jia, MD, Principal investigator, Beijing Tiantan HospitalKe Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968053
- Sponsor's protocol ID
- DT-MiNi
- Acronym
- DT-MiNi
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Microplastics and Nanoplastics in Neurosurgery Patients
- ClinicalTrials.gov ID
- NCT05968053
- Acronym / sponsor ID
- DT-MiNi / DT-MiNi
- Conditions
- Carotid Artery Stenosis, Glioma, Intracranial Aneurysm, Intracranial Hemorrhages, Brain Tumor
- Keywords
- microplastics, nanoplastics, Intracranial Aneurysm, brain tumor, Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 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.
Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.
Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.
The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included patients age 18-80 years with any types of neurosurgery Excluded patients refuse to participate
Key inclusion criteria (2 listed)
- Age 18-80 years
- Any type of neurosurgery
Key exclusion criteria (1 listed)
- ·refusal of the patient to participate
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 |
|---|---|---|
| biological samples analysisbiological samples analysis | Diagnostic test | – |
Primary outcome
microplastics
Time frame: baseline, intraoperative
Detection of microplastics in human brain tissue and the blood undergoing neurosurgery
nanoplastics
Time frame: baseline, intraoperative
Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery
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 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Runting Li, MD principal investigator
Beijing Tiantan Hospital
Yitong Jia, MD principal investigator
Beijing Tiantan Hospital
Ke Wang, MD principal investigator
Beijing Tiantan Hospital
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 Carotid Artery Stenosis and Glioma, run by Beijing Tiantan Hospital at 1 site in China.
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 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 23 Jan 2025. 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 China. 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 Xiaolin Chen, MD (13810624845, cxl_bjtth@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microplastics (time frame: baseline, intraoperative). The study lists 2 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 23 Jan 2025.