xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968053</url>
    </required_header>
    <id_info>
      <org_study_id>DT-MiNi</org_study_id>
      <nct_id>NCT05968053</nct_id>
    </id_info>
    <brief_title>Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)</brief_title>
    <acronym>DT-MiNi</acronym>
    <official_title>Presence of Microplastics and Nanoplastics in Neurosurgery Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Tiantan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Tiantan Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Plastic particles are a ubiquitous pollutant in the living environment and food chain, so&#xD;
        far, plenty of studies have reported the internal exposure of microplastics and nanoplastics&#xD;
        in human tissues and enclosed body fluids.&#xD;
  &#xD;
        Neurosurgery is the only department that can open the skull. In addition to blood and&#xD;
        cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether&#xD;
        any of these microplastics and nanoplastics are present remains a mystery. This prospective&#xD;
        observational study will harvest biological samples of neurosurgery patients.&#xD;
  &#xD;
        The objective of this research is to be able to detect microplastics and nanoplastics on&#xD;
        blood and operation samples of neurosurgery patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>microplastics</measure>
      <time_frame>baseline, intraoperative</time_frame>
      <description>Detection of microplastics in human brain tissue and the blood undergoing neurosurgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>nanoplastics</measure>
      <time_frame>baseline, intraoperative</time_frame>
      <description>Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery</description>
    </primary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Carotid Artery Stenosis</condition>
    <condition>Glioma</condition>
    <condition>Intracranial Aneurysm</condition>
    <condition>Intracranial Hemorrhages</condition>
    <condition>Brain Tumor</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>biological samples analysis</intervention_name>
      <description>biological samples analysis</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Included patients age 18-80 years with any types of neurosurgery Excluded patients refuse&#xD;
          to participate&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-80 years&#xD;
  &#xD;
            -  Any type of neurosurgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          ·refusal of the patient to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Runting Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Tiantan Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yitong Jia, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Tiantan Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ke Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Tiantan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaolin Chen, MD</last_name>
      <phone>13810624845</phone>
      <email>cxl_bjtth@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fa Lin, MD</last_name>
      <phone>13681107240</phone>
      <email>13681107240@163.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
      <investigator_full_name>Xiaolin Chen, MD</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>microplastics</keyword>
    <keyword>nanoplastics</keyword>
    <keyword>Intracranial Aneurysm</keyword>
    <keyword>brain tumor</keyword>
    <keyword>Carotid Artery Stenosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Neoplasms</mesh_term>
      <mesh_term>Intracranial Aneurysm</mesh_term>
      <mesh_term>Intracranial Hemorrhages</mesh_term>
      <mesh_term>Carotid Stenosis</mesh_term>
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968053
  org study id: DT-MiNi
  nct id: NCT05968053
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: microplastics
  time frame: baseline, intraoperative
  description: Detection of microplastics in human brain tissue and the blood undergoing neurosurgery
  measure: nanoplastics
  time frame: baseline, intraoperative
  description: Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery
  intervention type: Diagnostic Test
  intervention name: biological samples analysis
  description: biological samples analysis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Runting Li, MD
  role: Principal Investigator
  affiliation: Beijing Tiantan Hospital
  last name: Yitong Jia, MD
  role: Principal Investigator
  affiliation: Beijing Tiantan Hospital
  last name: Ke Wang, MD
  role: Principal Investigator
  affiliation: Beijing Tiantan Hospital
  last name: Xiaolin Chen, MD
  phone: 13810624845
  email: cxl_bjtth@163.com
  last name: Fa Lin, MD
  phone: 13681107240
  email: 13681107240@163.com
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Tiantan Hospital
  investigator full name: Xiaolin Chen, MD
  investigator title: Director
  mesh term: Brain Neoplasms
  mesh term: Intracranial Aneurysm
  mesh term: Intracranial Hemorrhages
  mesh term: Carotid Stenosis
  mesh term: Aneurysm
  mesh term: Hemorrhage
  sharing ipd: Undecided