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

Document Cover page 
Official Title of the Study 
- 
A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the 
Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study 
NCT Number: 
2017-07-10 
 
 
 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 1 / 8 
 
Research Protocol 
 
Brief Title: 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 
 
 
PRINCIPAL INVESTIGATOR:  
Other investigators:  
 
 
 
 
Institution and address: Division of Pulmonology and Critical Care Medicine, Ulsan University Hospital, 
University of Ulsan, Ulsan, South KOREA 
 
877, Bangeojin Sunhwando-ro, Dong-gu, Ulsan, Republic of KOREA. 44033 
 
Sponsor: University of Ulsan 
 
Collaborators: Ulsan University Hospital 
 
 
INDEX. 
 
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 
 
 
SCOPE  

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 2 / 8 
 
 
Study Description 
 
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 who were 
diagnosed by 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. 
 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 3 / 8 
 
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. 
 
 
SAMPLE SIZE 
 
Estimated Enrollment: 400 participants 
Observational Model: 
Cohort 
Time Perspective: 
Prospective 
Target Follow-Up Duration: 
3 Years 
 
In a preliminary study, one case of ocular toxocariasis (OT) among 12 cases of pulmonary toxocariasis (PT) 
was diagnosed (about 8%). 
 
Based on this, the investigators aimed at 400 pulmonary toxocariasis (PT): 32 ocular toxocariasis (OT). 
Statistical analysis 
All analyses in this study will be pre-specified. Statistical analysis will be performed using SPSS 21 and 
Graphpad PRISM 6.0. The results will be expressed as means ± SE. Summary data will be reported as mean 
± SEM. Statistical significance will be confirmed at a p value of <0.05. 
 
Parametric statistical tests: Student T-test, paired t- test, One-way ANOVA, Fisher’s extract test, Chi-square 
Non-parametric statistical tests: Mann-Whitney U test, Wilcoxon signed rank test  
: simple linear regression, multiple regression analysis 
 
 
Predictive side effects and precautions for the study 
 
In the present study, blood tests such as CBC, eosinophil count, toxocara Ab, and ocular examinations for 
screening purposes will be generally performed. 
The results of this study suggest that there is no additional side effect because it is a common blood test and 
ocular examination. 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 4 / 8 
 
 
 
Consideration of the safety of the subjects (test suspension, serious adverse reaction / countermeasures for 
adverse reactions, etc.) 
 
Although there is no additional side effect of this study, if the adverse reaction occurs, it will be stopped 
immediately. The investigator will notify the patient immediately. 
 
 
How to secure research ethics 
 
All the investigators will strictly observe the Declaration of Helsinki, Ethical Principles for Medical 
Research Involving Human Subjects, which defines the specific purpose, method and ethics of medical 
research. 
 All the investigators participating in this study will comply with the measures necessary for securing the 
ethics of this study, that is, to guarantee autonomy of patient participation, to provide sufficient explanation, 
to guarantee full withdrawal and to prohibit the privacy of patients. 
 
Study Design 
 
Study Type: 
Observational (closs sectional, cohort)  
Estimated Enrollment: 400 participants 
Observational Model: 
Cohort 
Time Perspective: 
Prospective 
Target Follow-Up Duration: 
3 Years 
 
 
Actual Study Start Date:  July 10, 2017 
Estimated Primary Completion Date: 
July 31, 2020 
Estimated Study Completion Date: 
July 31, 2020 
 
 
Outcome Measures 
 
1) Primary Outcome Measure: 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. 
 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 5 / 8 
 
 
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] 
 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 6 / 8 
 
- 
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) 
 
 
 
Eligibility Criteria 
 
1) Eligible for Study: 
18 Years and older 
2) Sexes Eligible for Study: All 
3) Gender Based: No 
4) Accepts Healthy Volunteers: 
No 
5) Sampling Method: 
Probability Sample 
 
Study Population 
 
1) 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. 
. 
 
2) 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: 
 
1) Aged 18 years and older 
2) Patient who has positive result of Toxocara Ab 
3) Patient who has history of eating of law animal liver or meat 
4) Patient who has the chest diagnostic image tests (chest X-ray, chest CT) with migrating ground glass 
opacity or nodular lesions. 
 
Exclusion Criteria: 
 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 7 / 8 
 
1) Age < 18 years 
2) Pregnant woman 
3) Malignant patient 
4) Patient who has pulmonary infectious lesion such as pneumonia, fungus and tuberculosis 
5) Patients who were diagnosed by benign or malignant pulmonary nodule 
6) Patient who was not consented 
 
Contacts and Locations 
 
Contacts :  
Locations: South Korea  
     
Ulsan University Hospital, 877 Bangeojin Sunwhan-doro, Ulsan, South Korea, 44033 
  
    
      
 
 
Other Study ID Numbers: 
UUH 2017-06-012-001 
 
 
 
References  
 
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4. 
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1757-1764 (2014). 

 
Approved 
by 
Ulsan 
University Hospital IRB 
Valid from: July 10, 2017      through  July 31, 2020 
IRB#: UUH 2017-06-012-001 
Brief Study Title: A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary 
Toxocariasis, and Ocular Toxocariasis Cohort 
 
Template Version Date: 10/07/2017                 Page 8 / 8 
 
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       Involving Human Subjects. Bulletin of the World Health Organization 79 (4), 373-374 (2001).