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A Study for the Ocular Toxocariasis Patients With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort

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ClinicalTrials.gov Identifier: NCT03814837
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Ulsan University Hospital
Information provided by (Responsible Party):
Kwang Won Seo, University of Ulsan

Brief Summary:
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.

Condition or disease
Toxocariasis Ocular Toxocariasis Pulmonary Toxocariasis Ground Glass Opacity (GGO) Toxocara Canis Infection (Canine Roundworms) Law Liver Law Meat Serum Toxocara Antibody Toxocara Larva Migrans

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of patients with pulmonary toxocariasis (PT) [ Time Frame: at baseline ]
    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.

  2. Number of patients with ocular toxocariasis (OT) [ Time Frame: at baseline ]
    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.

  3. Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT), [ Time Frame: at baseline ]
    Patients who have ocular toxocariasis (OT) with pulmonary toxocariasis (PT)


Secondary Outcome Measures :
  1. Incidence of Cysticercosis [ Time Frame: at baseline ]
    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)

  2. Incidence of Sparganosis [ Time Frame: at baseline ]
    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)

  3. Incidence of Clonorchiasis [ Time Frame: at baseline ]
    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)

  4. Incidence of Paragonimiasis [ Time Frame: at baseline ]
    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)

  5. Incidence of Anisakiasis [ Time Frame: at baseline ]
    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)

  6. Clinical course of the patients with ocular toxocariasis (OT) after treatment [ Time Frame: 3 years ]
    Follow-up : ocular toxocariasis cohort (clinical course of the patients with ocular toxocariasis (OT) after treatment by ophthalmologists)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The investigators defined pulmonary toxocariasis (PT) as a positive form of serum toxocara Ab and migrating pulmonary GGOs or nodular lesions.

Ocular toxocariasis (OT) is defined by the clinical manifestation of intraocular infection by Toxocara larvae and a positive form of serum toxocara Ab.

Criteria

Inclusion Criteria:

  • Aged 18 years and older
  • Patient who has positive result of Toxocara Ab
  • Patient who has history of eating of law animal liver or meat
  • Patient who has the chest diagnostic image tests (chest X-ray, chest CT) with migrating ground glass opacity or nodular lesions.

Exclusion Criteria:

  • Age < 18 years
  • Pregnant woman
  • Malignant patient
  • Patient who has pulmonary infectious lesion such as pneumonia, fungus and tuberculosis
  • Patients who were diagnosed by benign or malignant pulmonary nodule
  • Patient who was not consented

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814837


Contacts
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Contact: Kwang Won Seo, M.D. +82-10-9709-9138 kwseo@uuh.ulsan.kr

Locations
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Korea, Republic of
Ulsan University Hospital, 877 Bangeojin Sunwhando-ro Recruiting
Ulsan, Korea, Republic of, 44033
Contact: Kwang Won Seo, M.D.    +82-10-9709-9138    kwseo@uuh.ulsan.kr   
Sponsors and Collaborators
University of Ulsan
Ulsan University Hospital
Investigators
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Principal Investigator: Kwang Won Seo, M.D. Ulsan University Hospital
  Study Documents (Full-Text)

Documents provided by Kwang Won Seo, University of Ulsan:

Additional Information:

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Responsible Party: Kwang Won Seo, Associate professor, division of pulmonology, dept. of internal medicine, University of Ulsan
ClinicalTrials.gov Identifier: NCT03814837     History of Changes
Other Study ID Numbers: UUH 2017-06-012-001
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Toxocariasis
Larva Migrans
Helminthiasis, Animal
Helminthiasis
Parasitic Diseases
Ascaridida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases, Animal
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases