臨床研究等提出・公開システム

Date of registration	Feb. 29, 2024
Last modified on	May. 13, 2024
Trial ID	jRCT1030230668

Scientific Title	Clinical performance study of AIA-CL PS-PLA1 (Phosphatidylserine-specific Phos pholipase A1) assay reagent for systemic lupus erythematosus (SLE)
Public Title	Clinical performance study of PS-PLA1 assay reagent for SLE

Contact for Scientific Queries	Name	Fujio Keishi
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-338155411
	E-mail	fujiok-int@h.u-tokyo.ac.jp
Contact for Public Queries	Name	Shoda Hirofumi
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
	Telephone	+81-338155411
	E-mail	shodah-int@h.u-tokyo.ac.jp

Recruitment status	Recruiting

Study Design
Anticipated date of first enrollment		Feb. 29, 2024
Target sample size		300
Study Type		Observational



	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	SLE patients (untreated, treated intervention), non-SLE connective tissue disease patients (rheumatoid arthritis, other antinuclear antibody-related connective tissue diseases [Sjogren's syndrome, systemic sclerosis, polymyositis/dermatomyositis, mixed connective tissue disease], antiphospholipid antibody syndrome), non-connective tissue disease subjects
	Exclusion Criteria	1) Patients with thyroid disorders (Graves' disease, thyroiditis, Plummer's disease, Hashimoto's disease) 2) Pregnant women 3) Non-connective tissue disease subjects who are antinuclear antibody positive
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		SLE, non-SLE connective tissue diseases, non-connective tissue diseases
Primary Outcome(s)		Discriminatory evaluation of SLE using PS-PLA1
Secondary Outcome(s)		Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) by ROC analysis for PS-PLA1 and anti-ds-DNA antibodies. Transition of PS-PLA1, anti-ds-DNA antibodies, and SLEDAI values after therapeutic intervention in SLE patients.

Primary Sponsor	TOSOH Corporation

Source of Monetary Support / Secondary Sponsor	TOSOH Corporation
Secondary Sponsor

Name of Certified Review Board	Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1, Hongo Bunkyo-ku, Tokyo, Tokyo
Approval Status	Approval
Date of approval	Jan. 05, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 13, 2024	(this page)	Changes
1	Feb. 29, 2024	Detail

List of change history