NCT03814837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

January 9, 2019

Last Update Submit

January 22, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Incidence of Cysticercosis

    at baseline

  • Incidence of Sparganosis

    at baseline

  • Incidence of Clonorchiasis

    at baseline

  • Incidence of Paragonimiasis

    at baseline

  • Incidence of Anisakiasis

    at baseline

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulsan University Hospital, 877 Bangeojin Sunwhando-ro

Ulsan, 44033, South Korea

RECRUITING

MeSH Terms

Conditions

ToxocariasisLarva MigransToxocara canis infection (canine roundworms)

Condition Hierarchy (Ancestors)

Helminthiasis, AnimalHelminthiasisParasitic DiseasesInfectionsAscaridida InfectionsSecernentea InfectionsNematode InfectionsParasitic Diseases, AnimalAnimal DiseasesSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kwang Won Seo, M.D.

    Ulsan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwang Won Seo, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, division of pulmonology, dept. of internal medicine

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 24, 2019

Study Start

July 10, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations