Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)

• Sponsor: Beijing Tiantan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05968053
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis; Glioma; Intracranial Aneurysm; Intracranial Hemorrhages; Brain Tumor	Diagnostic Test: biological samples analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Presence of Microplastics and Nanoplastics in Neurosurgery Patients
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 30, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Outcome Measures

Primary Outcome Measures

1. microplastics [baseline, intraoperative]

   Detection of microplastics in human brain tissue and the blood undergoing neurosurgery

2. nanoplastics [baseline, intraoperative]

   Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-80 years

• Any type of neurosurgery

Exclusion Criteria:

·refusal of the patient to participate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beijing Tiantan Hospital

Investigators

• Principal Investigator: Runting Li, MD, Beijing Tiantan Hospital
• Principal Investigator: Yitong Jia, MD, Beijing Tiantan Hospital
• Principal Investigator: Ke Wang, MD, Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaolin Chen, MD, Director, Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT05968053
• Other Study ID Numbers: DT-MiNi
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaolin Chen, MD, Director, Beijing Tiantan Hospital: microplastics; nanoplastics; Intracranial Aneurysm; brain tumor; Carotid Artery Stenosis
• Additional relevant MeSH terms: Brain Neoplasms; Intracranial Aneurysm; Intracranial Hemorrhages; Carotid Stenosis; Aneurysm; Hemorrhage

Study Results

No Results Posted as of Aug 1, 2023