UMIN-CTR Clinical Trial

Basic information
Public title	Incidence of immune checkpoint inhibitor-induced arthritis
Acronym	Systematic review
Scientific Title	Incidence of immune checkpoint inhibitor-induced arthritis
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. Inflammatory arthritis has been the most commonly reported rheumatologic irAE. 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 arthralgia and arthritis will be calculated. Meta-analysis will be performed to compare the incidence of arthralgia and arthritis 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
Email	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
Email	kaoru_t@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

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
Email	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
Publication of results	Published

Result
URL related to results and publications	https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keac519/6693623?
Number of participants that the trial has enrolled	14377
Results	Please refer to the following: Rheumatology (Oxford). 2022 Sep 7;keac519. doi: 10.1093/rheumatology/keac519. Online ahead of print.
Results date posted	2022 Year 10 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 09 Month 07 Day
Baseline Characteristics	Please refer to the following: Rheumatology (Oxford). 2022 Sep 7;keac519. doi: 10.1093/rheumatology/keac519. Online ahead of print.
Participant flow	Please refer to the following: Rheumatology (Oxford). 2022 Sep 7;keac519. doi: 10.1093/rheumatology/keac519. Online ahead of print.
Adverse events	Please refer to the following: Rheumatology (Oxford). 2022 Sep 7;keac519. doi: 10.1093/rheumatology/keac519. Online ahead of print.
Outcome measures	Please refer to the following: Rheumatology (Oxford). 2022 Sep 7;keac519. doi: 10.1093/rheumatology/keac519. Online ahead of print.
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. Hematological diseases will be included. Intervention: ICI monotherapy or ICI combination therapy. Comparison: Chemotherapy. Outcomes: Arthralgia or arthritis. 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	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051385