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

Toxocariasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03814837
• Other study ID #: UUH 2017-06-012-001
• Status: Recruiting
• Start date: July 10, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2019
• Source: University of Ulsan
• Contact: Kwang Won Seo, M.D.
• Phone: +82-10-9709-9138
• Email: kwseo[@]uuh.ulsan.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital, 877 Bangeojin Sunwhando-ro	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulsan	Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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