NCT05968053

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

July 6, 2023

Last Update Submit

January 21, 2025

Conditions

Keywords

microplasticsnanoplasticsIntracranial Aneurysmbrain tumorCarotid Artery Stenosis

Outcome Measures

Primary Outcomes (2)

  • microplastics

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

    baseline, intraoperative

  • nanoplastics

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

    baseline, intraoperative

Interventions

biological samples analysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Included patients age 18-80 years with any types of neurosurgery Excluded patients refuse to participate

You may qualify if:

  • Age 18-80 years
  • Any type of neurosurgery

You may not qualify if:

  • ·refusal of the patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Carotid StenosisGliomaIntracranial AneurysmIntracranial HemorrhagesBrain Neoplasms

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueIntracranial Arterial DiseasesAneurysmHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by Site

Study Officials

  • Runting Li, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Yitong Jia, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Ke Wang, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolin Chen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 1, 2023

Study Start

September 25, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations