UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044960 |
|---|---|
| Receipt number | R000051371 |
| Scientific Title | Incidence of immune checkpoint inhibitor-related myositis |
| Date of disclosure of the study information | 2021/07/27 |
| Last modified on | 2024/12/16 10:12:09 |
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Basic information
Public title
Incidence of immune checkpoint inhibitor-related myositis
Acronym
Systematic review
Scientific Title
Incidence of immune checkpoint inhibitor-related myositis
Scientific Title:Acronym
Systematic review
Region
| Japan |
Condition
Condition
Solid tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Immune checkpoint inhibitors (ICIs) have provided durable responses and improved patient overall survival in solid tumors. However, ICIs can induce several immune-related adverse events (irAE) including musculoskeletal irAEs. Myositis is an increasingly recognized irAE. Although ICI-associated myositis remains relatively uncommon, it can be severe and sometimes even fatal. Therefore, we will conduct systematic review and meta-analysis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The odds ratio (OR) of any grade myositis will be calculated. Meta-analysis will be performed to compare the incidence of myositis between the treatment arm with ICIs and the arm with chemotherapy.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The published study designed as a randomized clinical trial (RCT).
(2) The experimental group of the study was treated with at least one type of ICIs with or without other systemic chemotherapy and the control group.
(3) The study with three arms where ICI is included at least one arm.
(4) The patients were clinically diagnosed with any solid tumor.
(5) The study illustrates the outcome of myositis.
(6) Only full-text papers are used to analyze.
Key exclusion criteria
(1) Systematic review or meta-analysis articles.
(2) Retrospective analysis.
(3) Single prospective cohort study without a control group.
(4) Non-RCT.
(5) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria.
(6) Studies with no or insufficient safety results at the time of the literature search.
(7) Studies published in languages other than English.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Graduate School of Medicine
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2630
kaoru_t@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 | 07 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fimmu.2021.803410/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fimmu.2021.803410/full
Number of participants that the trial has enrolled
12866
Results
Please refer to the following:
Front Immunol
. 2021 Dec 6;12:803410. doi: 10.3389/fimmu.2021.803410.
Results date posted
| 2024 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 06 | Day |
Baseline Characteristics
Please refer to the following:
Front Immunol
. 2021 Dec 6;12:803410. doi: 10.3389/fimmu.2021.803410.
Participant flow
Please refer to the following:
Front Immunol
. 2021 Dec 6;12:803410. doi: 10.3389/fimmu.2021.803410.
Adverse events
Please refer to the following:
Front Immunol
. 2021 Dec 6;12:803410. doi: 10.3389/fimmu.2021.803410.
Outcome measures
Please refer to the following:
Front Immunol
. 2021 Dec 6;12:803410. doi: 10.3389/fimmu.2021.803410.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | 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
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in August 2021.
RCTs meeting the following criteria will be considered for inclusion:
Participants: The patients were clinically diagnosed with any solid tumor. Tumor type is not questioned since safety profile is not largely affected by cancer type as long as the same regimen was selected.
Intervention: ICI monotherapy or ICI combination therapy.
Comparison: Chemotherapy.
Outcomes: Myositis.
Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Quality assessment:
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials.
Subgroup analysis:
Subgroup analysis based on regimen will be conducted.
Management information
Registered date
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051371
