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/NCT05983536</url>
    </required_header>
    <id_info>
      <org_study_id>89269678</org_study_id>
      <nct_id>NCT05983536</nct_id>
    </id_info>
    <brief_title>The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)</brief_title>
    <official_title>The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qianfoshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the&#xD;
        detection of HIV antigens and antibodies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and&#xD;
        antibodies in the serum of patients with tumor and blood diseases, and then confirmed by&#xD;
        using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2)&#xD;
        antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for&#xD;
        HIV assay in patients with tumor and hematological diseases was calculated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>The HIV Ab/Ag results</measure>
      <time_frame>through study completion, an average of 1.5 year</time_frame>
      <description>The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>HIV Seropositivity</condition>
    <condition>Cancer</condition>
    <condition>Blood Disease</condition>
    <arm_group>
      <arm_group_label>Cancer patients</arm_group_label>
      <description>Cancer patints that confirmed by pathological examination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with blood diseases</arm_group_label>
      <description>Bone marrow aspiration and biopsy confirmed the blood disease</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>HIV Ag +Ab Assay Kit (Sysmex)</intervention_name>
      <description>Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.</description>
      <arm_group_label>Cancer patients</arm_group_label>
      <arm_group_label>Patients with blood diseases</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Cancer patients and blood disease patients with age over 18 and have an HIV test in that&#xD;
          very day.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of tumor Disease or blood disease&#xD;
  &#xD;
            -  Blood samples must meet the test requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xia Zhao, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qianfoshan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hanxiang Chen, Ph.D.</last_name>
      <phone>0531-89269678</phone>
      <email>okayhensen@163.com</email>
    </overall_contact>
    <reference>
      <citation>Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028.</citation>
      <PMID>35512447</PMID>
    </reference>
    <reference>
      <citation>Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0.</citation>
      <PMID>33441741</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Seropositivity</mesh_term>
      <mesh_term>Hematologic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The planed will be shared after the clinical trial is completed and the patent protection is obtained</ipd_description>
    </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/NCT05983536
  org study id: 89269678
  nct id: NCT05983536
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the
        detection of HIV antigens and antibodies.
  First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and
        antibodies in the serum of patients with tumor and blood diseases, and then confirmed by
        using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2)
        antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for
        HIV assay in patients with tumor and hematological diseases was calculated.
  observational model: Cohort
  time perspective: Prospective
  measure: The HIV Ab/Ag results
  time frame: through study completion, an average of 1.5 year
  description: The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.
  arm group label: Cancer patients
  description: Cancer patints that confirmed by pathological examination
  arm group label: Patients with blood diseases
  description: Bone marrow aspiration and biopsy confirmed the blood disease
  intervention type: Diagnostic Test
  intervention name: HIV Ag +Ab Assay Kit (Sysmex)
  description: Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.
  arm group label: Cancer patients
  arm group label: Patients with blood diseases
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Xia Zhao, Master
  role: Principal Investigator
  affiliation: Qianfoshan Hospital
  last name: Hanxiang Chen, Ph.D.
  phone: 0531-89269678
  email: okayhensen@163.com
  citation: Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028.
  PMID: 35512447
  citation: Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0.
  PMID: 33441741
  responsible party type: Sponsor
  mesh term: HIV Seropositivity
  mesh term: Hematologic Diseases
  sharing ipd: Undecided
  ipd description: The planed will be shared after the clinical trial is completed and the patent protection is obtained