Detection of Microplastics and Nanoplastics in Neurosurge... | NCT05968053

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

NCT05968053

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Jan 23, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Carotid Artery Stenosis
Glioma
Intracranial Aneurysm
Intracranial Hemorrhages
Brain Tumor

Interventions

biological samples analysis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 6, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biological samples analysis	Diagnostic Test	biological samples analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80 years
Any type of neurosurgery

Exclusion Criteria:

·refusal of the patient to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaolin Chen, MD	Contact	13810624845		cxl_bjtth@163.com
Fa Lin, MD	Contact	13681107240		13681107240@163.com

Overall Officials

Name	Affiliation	Role
Runting Li, MD	Beijing Tiantan Hospital	Principal Investigator
Yitong Jia, MD	Beijing Tiantan Hospital	Principal Investigator
Ke Wang, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality	100070	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016893	Carotid Stenosis
D005910	Glioma
D002532	Intracranial Aneurysm
D020300	Intracranial Hemorrhages
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided