UMIN-CTR Clinical Trial

Basic information
Public title	Severe anaphylaxis caused by intravenous anti-cancer drugs
Acronym	Anti-cancer Drugs & Severe Anaphylaxis
Scientific Title	Severe anaphylaxis caused by intravenous anti-cancer drugs
Scientific Title:Acronym	Anti-cancer Drugs & Severe Anaphylaxis
Region	Japan

Condition
Condition	Severe Anaphylaxis
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study was to assess the incidence of severe anaphylaxis that was caused by anti-cancer medications and elucidate the high-risk situation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of severe anaphylaxis that was caused by anti-cancer medications
Key secondary outcomes	high-risk situation

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All outpatients and in patients who underwent intravenous chemotherapy for any malignancy from January 1st, 2013 to October 30th, 2020
Key exclusion criteria	None
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Chemotherapy Center
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL	045-787-2800
Email	horitano@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Ethical Guidelines for Medical and Health Research Involving Human Subjects
Zip code	236-0004
Address	3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	horitano@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Yokohama City University

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanazawa, Yokohama, Japan
Tel	045-370-7627
Email	rinri@yokohama-cu.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	2021 Year 01 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 01 Month 03 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Electronic medical chart of patients with cancers who underwent intravenous chemotherapy from January 2013 to October 2020 in a single university hospital will be retrospectively reviewed. Non-epithelial malignancies such as sarcoma and leukemia will be also allowed for our analysis. "Severe anaphylaxis" will be judged by Brown's criteria: typical presentation of anaphylaxis and one or more of hypoxia, hypotension, and neurologic compromise. Agresti-Coull method was used to estimate 95% confidence interval (CI) of incidence.

Management information
Registered date	2021 Year 01 Month 03 Day
Last modified on	2021 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048952

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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