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

A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Kwang Won Seo, M.D.; Phone Number: +82-10-9709-9138; Email: kwseo@uuh.ulsan.kr

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 44033
    • Recruiting
    • Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
    • Contact: Kwang Won Seo, M.D.; Phone Number: +82-10-9709-9138; Email: kwseo@uuh.ulsan.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline
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.	at baseline
Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT),	Patients who have ocular toxocariasis (OT) with pulmonary toxocariasis (PT)	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at baseline
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)	at baseline
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)	at baseline
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)	at baseline
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)	at baseline
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)	3 years

Collaborators and Investigators

• Sponsor: University of Ulsan
• Collaborators: Ulsan University Hospital
• Investigators: Principal Investigator: Kwang Won Seo, M.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Parasitic Diseases, Animal; Skin Diseases, Parasitic; Skin Diseases, Infectious; Secernentea Infections; Nematode Infections; Helminthiasis; Ascaridida Infections; Helminthiasis, Animal; Toxocariasis; Larva Migrans
• Other Study ID Numbers: UUH 2017-06-012-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No