UMIN-CTR Clinical Trial

Basic information
Public title	Serum ferritin, HO-1, and CD163 for the diagnosis of adult-onset Still's disease: a multicenter study
Acronym	Serum ferritin, HO-1, and CD163 in adult-onset Still's disease
Scientific Title	Serum ferritin, HO-1, and CD163 for the diagnosis of adult-onset Still's disease: a multicenter study
Scientific Title:Acronym	Serum ferritin, HO-1, and CD163 in adult-onset Still's disease
Region	Japan

Condition
Condition	Definite and suspected adult-onset Still's disease, systemic-onset juvenile idiopathic arthritis, rheumatic diseases, infectious diseases, malignancies
Classification by specialty	Medicine in general Hematology and clinical oncology Clinical immunology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Yamaguchi's criteria is sensitive and specific for the diagnosis of adult-Still's disease (AOSD) and has been used worldwide over the past few decades. However, elevation of serum ferritin, which is a specific in the disease, is not included in the criteria. Moreover, differential diagnosis with infectious diseases, malignancies, and rheumatic diseases are difficult.
Basic objectives2	Others
Basic objectives -Others	To improve the sensitivity and specificity for the diagnosis of AOSD, we are planning to measure serum ferritin, HO-1, and CD163, and evaluate their use in the diagnosis of AOSD along with the components in Yamaguchi's criteria. We also planning to monitor these markers during the course of disease.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnosis of adult-onset Still's disease
Key secondary outcomes	Major and minor components in Yamaguchi's criteria, laboratory data, serum ferritin, HO-1, and serum CD163

Base
Study type

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Blood examination
Interventions/Control_2	Blood examination
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	Adult-onset Still's disease cases fulfilling Yamaguchi's criteria, and suspected cases, established cases for diagnosis of rheumatic diseases, infectious diseases, and malignancies, healthy controls.
Key exclusion criteria	None
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshiaki Ishigatsubo
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Internal Medicine and Clinical Immunology
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2630
Email	ishigats@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yohei Kirino
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Internal Medicine and Clinical Immunology
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2630
Homepage URL
Email	kirino@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine, Department of Internal Medicine and Clinical Immunology
Institute
Department

Funding Source
Organization	Donations from profit organizations
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Uehara Memorial Fundation Yokohama Medical Foundation for Advancement of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	佐賀大学医学部附属病院（佐賀県） 早良病院(福岡県) 飯塚病院(福岡県) 自治医科大学附属病院（栃木県） 横浜市立大学市民総合医療センター（神奈川県） 鹿児島大学病院（鹿児島県） 九州大学別府病院　大分県） 札幌医科大学医学部附属病院（北海道） 東京女子医科大学病院（東京都） 聖マリアンナ医科大学病院（神奈川県） 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 21 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	Completed
Date of protocol fixation	2014 Year 01 Month 10 Day
Date of IRB	2014 Year 01 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 10 Day
Last follow-up date	2017 Year 01 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 01 Month 09 Day

Other
Other related information

Management information
Registered date	2014 Year 01 Month 21 Day
Last modified on	2020 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015095