UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012912
Receipt number R000015095
Scientific Title Serum ferritin, HO-1, and CD163 for the diagnosis of adult-onset Still's disease: a multicenter study
Date of disclosure of the study information 2014/01/21
Last modified on 2020/01/27 14:32:20

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015095


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name