<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/NCT03814837</url>
  </required_header>
  <id_info>
    <org_study_id>UUH 2017-06-012-001</org_study_id>
    <nct_id>NCT03814837</nct_id>
  </id_info>
  <brief_title>A Study for the Ocular Toxocariasis Patients With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort</brief_title>
  <official_title>A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulsan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulsan</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>
      TOXOCARA Study is a prospective observational cohort study. The aim of this study is to&#xD;
      evaluate the incidence of ocular toxocariasis (OT) associated with pulmonary toxocariasis&#xD;
      (PT) in patients with chest diagnostic image tests (chest X-ray, chest CT) with migrating&#xD;
      ground glass opacity or nodular lesions. Also a cohort study is to track the results of&#xD;
      treatment for diagnosed ocular toxocariasis (OT) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Toxocara canis (also known as dog roundworm) is wide-reaching parasite of dogs and other&#xD;
      canids. It can spread between animals such as cats, pigs and cows by ingestion of worm eggs&#xD;
      from the feces of an infected animal.&#xD;
&#xD;
      In humans, two pathways of infection are known: first, ingestion of the eggs and second,&#xD;
      larvae encapsulated in the tissues of the infected animal.&#xD;
&#xD;
      The encapsulated larvae hatch in the small intestine and pass through the barrier to the&#xD;
      portal vein, the liver, the lung, the eye, etc. and remain as encapsulated larvae or survive&#xD;
      for a period of time.&#xD;
&#xD;
      Infection into humans has been reported through ingestion of uncooked liver of cows, pigs,&#xD;
      sheep, chickens, and meat (muscle).&#xD;
&#xD;
      When encapsulated larvae migrate to the body such as lungs, eosinophils activate and&#xD;
      proliferate to eliminate the parasites.&#xD;
&#xD;
      They can be expressed as ground glass opacity (GGO) or nodular lesion by aggregated&#xD;
      eosinophils, which are mistaken for lung cancer or pneumonia to be investigated.&#xD;
&#xD;
      Asthma exacerbation, cough and other symptoms of respiratory system could be revealed, but&#xD;
      often asymptomatic.&#xD;
&#xD;
      In this study, the investigators defined pulmonary toxocariasis (PT) as a positive form of&#xD;
      serum toxocara Ab and migrating pulmonary GGOs or nodular lesions in chest diagnostic image&#xD;
      tests (chest X-ray, chest CT) from the patient.&#xD;
&#xD;
      Also ocular toxocariasis (OT) is defined by the clinical manifestation of intraocular&#xD;
      infection by Toxocara larvae with a positive result of serum toxocara Ab.&#xD;
&#xD;
      Clinical manifestations of OT may also cause blindness of peripheral granuloma, optic&#xD;
      neuritis, chorioretinitis, conjunctivitis, keratitis, iridocyclitis and cataract.&#xD;
&#xD;
      The investigators want to investigate the incidence of OT associated with PT in patients with&#xD;
      chest diagnostic image tests (chest X-ray, chest CT) with migrating GGOs or nodular lesions.&#xD;
      Also a cohort study is to track the results of treatment for diagnosed OT patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Number of patients with pulmonary toxocariasis (PT)</measure>
    <time_frame>at baseline</time_frame>
    <description>Patients who have a positive result of serum toxocara Ab and migrating pulmonary GGOs or nodular lesions and history of eating of law animal liver or meat or history of having the pets such as dogs and cats.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with ocular toxocariasis (OT)</measure>
    <time_frame>at baseline</time_frame>
    <description>Patients who have the clinical manifestation of intraocular infection by Toxocara larvae and a positive result of serum toxocara Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions) or history of having the pets such as dogs and cats.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT),</measure>
    <time_frame>at baseline</time_frame>
    <description>Patients who have ocular toxocariasis (OT) with pulmonary toxocariasis (PT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Cysticercosis</measure>
    <time_frame>at baseline</time_frame>
    <description>Patient who have a positive result of serum cysticercosis Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Sparganosis</measure>
    <time_frame>at baseline</time_frame>
    <description>Patient who have a positive result of serum sparganum Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clonorchiasis</measure>
    <time_frame>at baseline</time_frame>
    <description>Patient who have a positive result of serum clonorchis sinensis Ab and history of eating of the law freshwater fish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Paragonimiasis</measure>
    <time_frame>at baseline</time_frame>
    <description>Patient who have a positive result of serum paragonimus westermani Ab and history of eating of the law freshwater crabs or crayfish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Anisakiasis</measure>
    <time_frame>at baseline</time_frame>
    <description>Patient who have a positive result of serum anisakis Ab and history of eating of the law oceanic fish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical course of the patients with ocular toxocariasis (OT) after treatment</measure>
    <time_frame>3 years</time_frame>
    <description>Follow-up : ocular toxocariasis cohort (clinical course of the patients with ocular toxocariasis (OT) after treatment by ophthalmologists)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Toxocariasis</condition>
  <condition>Ocular Toxocariasis</condition>
  <condition>Pulmonary Toxocariasis</condition>
  <condition>Ground Glass Opacity (GGO)</condition>
  <condition>Toxocara Canis Infection (Canine Roundworms)</condition>
  <condition>Law Liver</condition>
  <condition>Law Meat</condition>
  <condition>Serum Toxocara Antibody</condition>
  <condition>Toxocara Larva Migrans</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators defined pulmonary toxocariasis (PT) as a positive form of serum toxocara&#xD;
        Ab and migrating pulmonary GGOs or nodular lesions.&#xD;
&#xD;
        Ocular toxocariasis (OT) is defined by the clinical manifestation of intraocular infection&#xD;
        by Toxocara larvae and a positive form of serum toxocara Ab.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years and older&#xD;
&#xD;
          -  Patient who has positive result of Toxocara Ab&#xD;
&#xD;
          -  Patient who has history of eating of law animal liver or meat&#xD;
&#xD;
          -  Patient who has the chest diagnostic image tests (chest X-ray, chest CT) with&#xD;
             migrating ground glass opacity or nodular lesions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Malignant patient&#xD;
&#xD;
          -  Patient who has pulmonary infectious lesion such as pneumonia, fungus and tuberculosis&#xD;
&#xD;
          -  Patients who were diagnosed by benign or malignant pulmonary nodule&#xD;
&#xD;
          -  Patient who was not consented&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwang Won Seo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kwang Won Seo, M.D.</last_name>
    <phone>+82-10-9709-9138</phone>
    <email>kwseo@uuh.ulsan.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ulsan University Hospital, 877 Bangeojin Sunwhando-ro</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwang Won Seo, M.D.</last_name>
      <phone>+82-10-9709-9138</phone>
      <email>kwseo@uuh.ulsan.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulsan</investigator_affiliation>
    <investigator_full_name>Kwang Won Seo</investigator_full_name>
    <investigator_title>Associate professor, division of pulmonology, dept. of internal medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Toxocariasis</mesh_term>
    <mesh_term>Larva Migrans</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03814837/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03814837
org study id: UUH 2017-06-012-001
nct id: NCT03814837
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
TOXOCARA Study is a prospective observational cohort study. The aim of this study is to
      evaluate the incidence of ocular toxocariasis (OT) associated with pulmonary toxocariasis
      (PT) in patients with chest diagnostic image tests (chest X-ray, chest CT) with migrating
      ground glass opacity or nodular lesions. Also a cohort study is to track the results of
      treatment for diagnosed ocular toxocariasis (OT) patients.
Toxocara canis (also known as dog roundworm) is wide-reaching parasite of dogs and other
      canids. It can spread between animals such as cats, pigs and cows by ingestion of worm eggs
      from the feces of an infected animal.

      In humans, two pathways of infection are known: first, ingestion of the eggs and second,
      larvae encapsulated in the tissues of the infected animal.

      The encapsulated larvae hatch in the small intestine and pass through the barrier to the
      portal vein, the liver, the lung, the eye, etc. and remain as encapsulated larvae or survive
      for a period of time.

      Infection into humans has been reported through ingestion of uncooked liver of cows, pigs,
      sheep, chickens, and meat (muscle).

      When encapsulated larvae migrate to the body such as lungs, eosinophils activate and
      proliferate to eliminate the parasites.

      They can be expressed as ground glass opacity (GGO) or nodular lesion by aggregated
      eosinophils, which are mistaken for lung cancer or pneumonia to be investigated.

      Asthma exacerbation, cough and other symptoms of respiratory system could be revealed, but
      often asymptomatic.

      In this study, the investigators defined pulmonary toxocariasis (PT) as a positive form of
      serum toxocara Ab and migrating pulmonary GGOs or nodular lesions in chest diagnostic image
      tests (chest X-ray, chest CT) from the patient.

      Also ocular toxocariasis (OT) is defined by the clinical manifestation of intraocular
      infection by Toxocara larvae with a positive result of serum toxocara Ab.

      Clinical manifestations of OT may also cause blindness of peripheral granuloma, optic
      neuritis, chorioretinitis, conjunctivitis, keratitis, iridocyclitis and cataract.

      The investigators want to investigate the incidence of OT associated with PT in patients with
      chest diagnostic image tests (chest X-ray, chest CT) with migrating GGOs or nodular lesions.
      Also a cohort study is to track the results of treatment for diagnosed OT patients.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with pulmonary toxocariasis (PT)
time frame: at baseline
description: Patients who have a positive result of serum toxocara Ab and migrating pulmonary GGOs or nodular lesions and history of eating of law animal liver or meat or history of having the pets such as dogs and cats.
measure: Number of patients with ocular toxocariasis (OT)
time frame: at baseline
description: Patients who have the clinical manifestation of intraocular infection by Toxocara larvae and a positive result of serum toxocara Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions) or history of having the pets such as dogs and cats.
measure: Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT),
time frame: at baseline
description: Patients who have ocular toxocariasis (OT) with pulmonary toxocariasis (PT)
measure: Incidence of Cysticercosis
time frame: at baseline
description: Patient who have a positive result of serum cysticercosis Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions)
measure: Incidence of Sparganosis
time frame: at baseline
description: Patient who have a positive result of serum sparganum Ab and history of eating of law animal liver or meat. (and/or migrating pulmonary GGOs or nodular lesions)
measure: Incidence of Clonorchiasis
time frame: at baseline
description: Patient who have a positive result of serum clonorchis sinensis Ab and history of eating of the law freshwater fish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)
measure: Incidence of Paragonimiasis
time frame: at baseline
description: Patient who have a positive result of serum paragonimus westermani Ab and history of eating of the law freshwater crabs or crayfish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)
measure: Incidence of Anisakiasis
time frame: at baseline
description: Patient who have a positive result of serum anisakis Ab and history of eating of the law oceanic fish or its cuisine. (and/or migrating pulmonary GGOs or nodular lesions)
measure: Clinical course of the patients with ocular toxocariasis (OT) after treatment
time frame: 3 years
description: Follow-up : ocular toxocariasis cohort (clinical course of the patients with ocular toxocariasis (OT) after treatment by ophthalmologists)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwang Won Seo, M.D.
role: Principal Investigator
affiliation: Ulsan University Hospital
last name: Kwang Won Seo, M.D.
phone: +82-10-9709-9138
email: kwseo@uuh.ulsan.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Ulsan
investigator full name: Kwang Won Seo
investigator title: Associate professor, division of pulmonology, dept. of internal medicine
mesh term: Toxocariasis
mesh term: Larva Migrans
sharing ipd: No
provided document: 