UMIN-CTR Clinical Trial

Public title

Longitudinal study of patient involvement in anaphylaxis using a network of the Allergic Disease Medical Core Hospital

Acronym

Longitudinal study of anaphylactic patients

Scientific Title

Longitudinal study of patient involvement in anaphylaxis using a network of the Allergic Disease Medical Core Hospital

Scientific Title:Acronym

Longitudinal study of anaphylaxis using a network of the Allergic Disease Medical Core Hospital

Region

Japan

Condition

Allergy and Anaphylaxis

Classification by specialty

Clinical immunology	Pediatrics	Dermatology
Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We aim to identify the long-term management of patients with anaphylaxis.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Anaphylaxis recurrence rate after onset of anaphylaxis

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who developed anaphylaxis in the cooperating institution.
2) Patients who developed anaphylaxis and received an emergency visit or scheduled visit to the cooperating institution.
3) Patients who developed anaphylaxis and subsequently visited the collaborating institution.

Key exclusion criteria

1) Cases of anaphylaxis by oral food challenge or other induced tests.
2) Cases judged inappropriate by the physician.

Target sample size

500

Name of lead principal investigator

1st name	Sakura
Middle name
Last name	Sato

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Clinical Research Center for Allergy and Rheumatology

Zip code

252-0392

Address

18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa

TEL

042-742-8311

Email

ssakura8010@foodallergy.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Kodachi

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of pediatrics

Zip code

252-0392

Address

18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa

TEL

042-742-8311

Homepage URL

Email

r1219kt@jichi.ac.jp

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name

Organization

Japanese Society of Allergology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sagamihara Hospital Ethics Committee of the National Hospital Organization

Address

18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa

Tel

042-742-8311

Email

makino.megumi.bn@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

2022

Year

12

Month

01

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

Open public recruiting

Date of protocol fixation

2022

Year

09

Month

26

Day

Date of IRB

2022

Year

10

Month

18

Day

Anticipated trial start date

2022

Year

12

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research and Survey Items
<Methods>
The following information will be obtained from eligible patients via a web-based questionnaire at the time of study entry and at specific times (January, April, July, and October) during the following three years.

<Research Items>
First survey for participation in this study
1 E-mail address
2 Patient background (age, gender, number of previous anaphylaxis and its triggers, whether or not bronchial asthma is complicated and treated)
3 Details of anaphylaxis (triggers, physician's diagnosis or not, exercise-induced or not)
4 Possession of adrenaline self-injection products or not

The second survey and subsequent
1 Whether or not anaphylaxis has occurred since the last survey
2 If there has been an onset of anaphylaxis since the last survey, details of anaphylaxis (triggers, physician's diagnosis or not, exercise-induced or not), adrenaline self-injection products were used or not, emergency medical care was taken or not, a medical facility was visited or not.

Registered date

2022

Year

11

Month

29

Day

Last modified on

2023

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056531