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Status unknownNCT03814837Updated Jan 24, 2019

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

An observational study in Toxocariasis, Ocular Toxocariasis and Pulmonary Toxocariasis, sponsored by University of Ulsan. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-24.

Sponsored by University of Ulsan · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Toxocariasis
  • Ocular Toxocariasis
  • Pulmonary Toxocariasis
  • Ground Glass Opacity (GGO)
  • Toxocara Canis Infection (Canine Roundworms)
  • Law Liver
  • Law Meat
  • Serum Toxocara Antibody
  • Toxocara Larva Migrans
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Number of patients with pulmonary toxocariasis (PT)

    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.

    Time frame: at baseline

  2. Number of patients with ocular toxocariasis (OT)

    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.

    Time frame: at baseline

  3. Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT),

    Patients who have ocular toxocariasis (OT) with pulmonary toxocariasis (PT)

    Time frame: at baseline

Secondary outcomes

  1. Incidence of Cysticercosis

    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)

    Time frame: at baseline

  2. Incidence of Sparganosis

    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)

    Time frame: at baseline

  3. Incidence of Clonorchiasis

    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)

    Time frame: at baseline

  4. Incidence of Paragonimiasis

    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)

    Time frame: at baseline

  5. Incidence of Anisakiasis

    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)

    Time frame: at baseline

  6. Clinical course of the patients with ocular toxocariasis (OT) after treatment

    Follow-up : ocular toxocariasis cohort (clinical course of the patients with ocular toxocariasis (OT) after treatment by ophthalmologists)

    Time frame: 3 years

06

Study locations

1 of 1 sites recruiting
  • Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
    Ulsan, 44033, Korea, Republic of
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 10, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03814837
Lead sponsor
University of Ulsan
Collaborators
Ulsan University Hospital
Responsible party
Kwang Won Seo (Associate professor, division of pulmonology, dept. of internal medicine, University of Ulsan) — Principal investigator
First posted
Jan 24, 2019
Start date
Jul 10, 2017
Primary completion
Jul 31, 2020 (estimated)
Completion
Jul 31, 2020 (estimated)
Last update
Jan 24, 2019

Study contacts

Kwang Won Seo, M.D.
Contact
kwseo@uuh.ulsan.kr
+82-10-9709-9138
Kwang Won Seo, M.D.
principal investigator · Ulsan University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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