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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05968053
Other study ID # DT-MiNi
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Beijing Tiantan Hospital
Contact Xiaolin Chen, MD
Phone 13810624845
Email cxl_bjtth@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age 18-80 years - Any type of neurosurgery Exclusion Criteria: ·refusal of the patient to participate

Study Design


Intervention

Diagnostic Test:
biological samples analysis
biological samples analysis

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary microplastics Detection of microplastics in human brain tissue and the blood undergoing neurosurgery baseline, intraoperative
Primary nanoplastics Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery baseline, intraoperative
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