UMIN-ICDS Clinical Trial

Public title

National Hospital Organization Severe Hypereosinophilia Interspecialty Nationwide Elucidation Prospective Study

Acronym

NHO-SHINE

Scientific Title

National Hospital Organization Severe Hypereosinophilia Interspecialty Nationwide Elucidation Prospective Study

Scientific Title:Acronym

NHO-SHINE

Region

Japan

Condition

Marked peripheral blood eosinophilia (absolute eosinophil count at least 1,500 cells per microliter)

Classification by specialty

Medicine in general	Pneumology	Hematology and clinical oncology
Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This multicenter observational study aims to investigate the distribution of final diagnoses, clinical characteristics, and diagnostic trajectories among adults with peripheral blood eosinophil counts at least 1,500 cells per microliter across National Hospital Organization (NHO) hospitals and collaborating institutions in Japan.
A retrospective survey of all eligible patients at participating institutions will also be conducted to characterize the distribution of underlying diseases. Furthermore, comprehensive proteomic and cytokine analyses of blood and urine samples will be performed to explore novel biomarkers for differentiating eosinophilic disorders, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

Basic objectives2

Others

Basic objectives -Others

To characterize the distribution of underlying diseases, clinical features, and final diagnoses among patients with marked peripheral blood eosinophilia and to explore novel biomarkers for differential diagnosis.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1 Study A-1 (Prospective registry)
Distribution of final diagnoses among patients with peripheral blood eosinophil counts at least 1,500 cells per microliter, assessed as the proportion of patients diagnosed with each underlying disease, including EGPA, HES, and secondary eosinophilia, based on clinical records at the time of diagnosis.
2 Study A-2 (Retrospective survey)
Total number of patients with peripheral blood eosinophil counts at least 1,500 cells per microliter and the distribution of underlying diseases at participating institutions during the one-year period preceding data extraction.
3 Study B (Exploratory biomarker study)
Discriminative performance of blood- and urine-based protein expression profiles for differentiating eosinophilic disorders. Candidate biomarkers will be identified through comprehensive proteomic and cytokine analyses, and their diagnostic performance will be evaluated exploratorily using receiver operating characteristic (ROC) analysis and related methods.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Study A-1 (Prospective registry)
1. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter confirmed at least once.
2. Patients aged 20 years or older at the time of informed consent.
3. Patients who provide written informed consent to participate in the study.

Study A-2 (Retrospective survey)
1. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter.
2. Patients aged 20 years or older.
3. Patients who visited a participating institution during the one-year period preceding the designated data extraction date.

Study B (Exploratory biomarker study)
1. Patients enrolled in Study A-1.
2. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter.
3. Patients who have not yet received standard treatment for the underlying disease.
4. Patients aged 20 years or older at the time of informed consent.
5. Patients who provide separate written informed consent, including consent for blood and urine sample collection.

Key exclusion criteria

Study A-1 and Study B
1. Patients who do not provide written informed consent.
2. Patients considered unsuitable for participation by the principal investigator or study investigators.

Study A-2
1. Patients with substantial missing clinical data that preclude appropriate analysis.
2. Patients considered unsuitable for inclusion by the principal investigator.

Target sample size

1500

Name of lead principal investigator

1st name	Yosuke
Middle name
Last name	Kamide

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1 Sakuradai, Minamiku Sagamihara, Kanagawa, Japan

TEL

0427428311

Email

m08702012@gmail.com

Name of contact person

1st name	Yosuke
Middle name
Last name	Kamide

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1 Sakuradai, Minamiku Sagamihara, Kanagawa, Japan

TEL

042-742-8311

Homepage URL

Email

m08702012@gmail.com

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Hospital Organization Central Ethics Review Committee for Clinical Research

Address

2-5-21 Higashigaoka, Meguro-ku, Tokyo 152-8621, Japan

Tel

03-5712-5075

Email

700-kenkyu@mail.hosp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2028

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter observational study conducted at National Hospital Organization (NHO) hospitals and collaborating institutions in Japan. The study consists of three components: Study A-1, Study A-2, and Study B.
Study A-1 is a prospective cohort study enrolling adults aged 20 years or older with a peripheral blood eosinophil count of at least 1500 cells per microliter confirmed at least once. Final diagnoses, clinical characteristics, time to diagnosis, and organ involvement will be prospectively evaluated (target sample size: 500).
Study A-2 is a retrospective cross-sectional study investigating all patients aged 20 years or older with a peripheral blood eosinophil count of at least 1500 cells per microliter during the preceding one-year period at participating institutions. The total number of eligible patients and the distribution of underlying diseases will be evaluated using electronic medical records (target sample size: 1000). An opt-out consent procedure will be used.
Study B is a prospective exploratory biomarker study involving patients enrolled in Study A-1 who have not yet received standard treatment for the underlying disease. Blood and urine samples will be collected once after obtaining separate written informed consent. Biomarkers for differentiating eosinophilic disorders will be explored (target sample size: 50).
No treatment intervention, randomization, or blinding will be performed.

Registered date

2026

Year

10

Month

20

Day

Last modified on

2026

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072517