ToxocariasisNCT03814837
A Study for the Ocular Toxocariasis Patients With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort
An observational study of Toxocariasis and Ocular Toxocariasis, run by University of Ulsan at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toxocariasis, Ocular Toxocariasis, Pulmonary Toxocariasis
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2017to 31 Jul 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
Ulsan, 44033
Kwang Won Seo, M.D., +82-10-9709-9138, kwseo@uuh.ulsan.kr
About this study
Official title: 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.
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.
- Conditions
- Toxocariasis, Ocular Toxocariasis, Pulmonary Toxocariasis, Ground Glass Opacity (GGO), Toxocara Canis Infection (Canine Roundworms), Law Liver
- Medical subject headings
- Toxocariasis, Larva Migrans, Toxocara canis infection (canine roundworms)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: at baseline
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start10 Jul 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxocariasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Ulsan
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan University Hospital
- Responsible party
- Principal investigator, Kwang Won Seo, University of Ulsan
- Investigators
- Kwang Won Seo, M.D., Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814837
- Sponsor's protocol ID
- UUH 2017-06-012-001
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Ocular Toxocariasis in the Patients Who Were Diagnosed With the Pulmonary Toxocariasis, and Ocular Toxocariasis Cohort: TOXOCARA Study
- ClinicalTrials.gov ID
- NCT03814837
- Acronym / sponsor ID
- UUH 2017-06-012-001
- Conditions
- Toxocariasis, Ocular Toxocariasis, Pulmonary Toxocariasis, Ground Glass Opacity (GGO), Toxocara Canis Infection (Canine Roundworms), Law Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of UlsanUniversity, hospital or other
- Collaborators
- Ulsan University Hospital
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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)
6 secondary outcomes
Incidence of Cysticercosis
Time frame: at baseline
Incidence of Sparganosis
Time frame: at baseline
Incidence of Clonorchiasis
Time frame: at baseline
Incidence of Paragonimiasis
Time frame: at baseline
Incidence of Anisakiasis
Time frame: at baseline
Clinical course of the patients with ocular toxocariasis (OT) after treatment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang Won Seo, M.D. principal investigator
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxocariasis and Ocular Toxocariasis, run by University of Ulsan at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwang Won Seo, M.D. (+82-10-9709-9138, kwseo@uuh.ulsan.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with pulmonary toxocariasis (PT) (time frame: at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.