Clinical trial NCT03814837: A Study for the Ocular Toxocariasis Patients With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort
Official title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: University of Ulsan
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
First posted: 2019-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with pulmonary toxocariasis (PT)
timeFrame: at baseline
measure: Number of patients with ocular toxocariasis (OT)
timeFrame: at baseline
measure: Number of patients with ocular toxocariasis (OT) among the patients with pulmonary toxocariasis (PT),
timeFrame: at baseline
Secondary outcomes:
measure: Incidence of Cysticercosis
timeFrame: at baseline
measure: Incidence of Sparganosis
timeFrame: at baseline
measure: Incidence of Clonorchiasis
timeFrame: at baseline
measure: Incidence of Paragonimiasis
timeFrame: at baseline
measure: Incidence of Anisakiasis
timeFrame: at baseline
measure: Clinical course of the patients with ocular toxocariasis (OT) after treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
Study officials:
affiliation: Ulsan University Hospital
name: Kwang Won Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: