UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042887 |
|---|---|
| Receipt number | R000048952 |
| Scientific Title | Severe anaphylaxis caused by intravenous anti-cancer drugs |
| Date of disclosure of the study information | 2021/01/03 |
| Last modified on | 2021/12/20 13:11:39 |
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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
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
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5584
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
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
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 | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048952
