UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060570 |
|---|---|
| Receipt number | R000069269 |
| Scientific Title | An Observational Study on Diseases Among Foreign Patients |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/03 18:27:12 |
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Basic information
Public title
Foreign Patient Disease Study
Acronym
FP Disease Study
Scientific Title
An Observational Study on Diseases Among Foreign Patients
Scientific Title:Acronym
FP-DISEASE Study
Region
| Japan |
Condition
Condition
Various diseases among foreign patients, including infectious diseases
Classification by specialty
| Medicine in general | Infectious disease | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the distribution and characteristics of diseases among foreign patients visiting the emergency department, with a particular focus on the prevalence and background factors of infectious diseases, in order to better understand the current status of emergency care for foreign patients.
Basic objectives2
Others
Basic objectives -Others
This study does not aim to evaluate treatment efficacy, safety, prognosis, or diagnostic accuracy, but rather aims to retrospectively clarify the distribution of diseases and the frequency and characteristics of infectious diseases among foreign patients presenting to the emergency department.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution and proportion of disease categories (infectious and non-infectious diseases) among foreign patients visiting the emergency department.
Key secondary outcomes
Prevalence and causes of infectious diseases among foreign patients
Differences in disease distribution according to country of origin or residency status
Associations between disease categories, triage acuity, and mode of arrival (ambulance or walk-in)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Foreign patients who visited our ER, operated by the Department of Emergency and General Medicine and Health Science at Nippon Medical School, on or after April 1, 2017, and whose electronic medical record data were available.
Key exclusion criteria
Patients with missing key clinical information or insufficient electronic medical record data required for analysis.
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Suzaki |
Organization
Nippon Medical School Hospital
Division name
Department of Emergency and General Medicine and Health Science
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3822-2131
mstnndr1@nms.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Suzaki |
Organization
Nippon Medical School Hospital
Division name
Department of Emergency and General Medicine and Health Science
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3822-2131
Homepage URL
mstnndr1@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Makoto Suzaki
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital, Center for Clinical Research
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3822-2131
nms_fuzokurinri@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nms.ac.jp/
Number of participants that the trial has enrolled
1436
Results
A total of 1,436 foreign patients who visited our emergency department between April 2017 and March 2024 (excluding cases with unknown country of origin) were retrospectively analyzed. Females accounted for 56% of the patients, and infectious diseases were the most frequent disease category, with respiratory infections being the most common.
Results date posted
| 2026 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics, including age, sex, mode of arrival, and disease categories, were collected from electronic medical records. Females accounted for 56% of participants, and infectious diseases were the most common disease category.
Participant flow
Among foreign patients who visited the emergency department during the study period, cases with unknown country of origin were excluded, resulting in 1,436 patients included in the analysis.
Adverse events
As this was a retrospective observational study, no adverse events related to the study were identified.
Outcome measures
The primary outcome was the distribution and proportion of disease categories (infectious and non-infectious diseases) among foreign patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective observational study conducted using existing electronic medical record data. Part of the results has been presented at a scientific meeting, and a manuscript is currently being prepared for submission to a peer-reviewed journal.
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069269
