UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of the concept of immune reconstitution syndrome not related to HIV infection with study for development of biomarkers
Acronym	Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers.
Scientific Title	Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers.
Scientific Title:Acronym	Establishment of the concept of non-HIV IRIS with study for development of biomarkers.
Region	Japan

Condition
Condition	immune reconstitution inflammatory syndrome (IRIS)
Classification by specialty	Pneumology Clinical immunology Infectious disease Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	When infectious diseases and organ disorders occur one after another during treatment of original diseases such as collagen disease, autoimmune disease, malignant tumor, and DIHS, it is easy to regard them as separate diseases. Without easy understanding of the pathological condition based on immune reconstitution, if the effective treatment for the original disease is easily reduced or stopped, not only the exacerbation of the original disease but also the immune reconstitution is accelerated, which may exacerbate the adverse event. The purpose of this research is the development of biomarkers that contribute to the diagnosis and onset prediction of non-HIV IRIS.
Basic objectives2	Others
Basic objectives -Others	We believe that immune-related adverse events (irAE) due to immune checkpoint inhibitors are also included in non-HIV IRIS. The final objective is to establish a disease concept and diagnostic criteria by clarifying biomarkers common to non-HIV IRIS and irAE, and to create a medical treatment algorithm.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	By comparing the group that developed the IRIS event with the group that did not develop the disease, a diagnostic biomarker with high sensitivity and specificity and an onset prediction biomarker are extracted from among cytokine / chemokine / hemocyte markers and viral amount.
Key secondary outcomes	Neutrophil / lymphocyte ratio at the start of treatment of the primary disease and at the onset of IRIS event

Base
Study type	Observational

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with drug-induced hypersensitivity syndrome, collagen disease / autoimmune disease before the start of immunomodulators, or patients who meet the diagnostic criteria for IRIS.
Key exclusion criteria	1) Those who have difficulty in visiting the hospital regularly 2) Those with severe anemia and less than (hemoglobin 9.0 g / mL) 3) Those who have difficulty in collecting saliva due to dry mouth 4) Patients who are judged to be ineligible according to the judgment of the research doctor.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hirohiko Middle name Last name Sueki
Organization	Showa University
Division name	Department of Dermatology
Zip code	142-8666
Address	1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
TEL	03-3784-8556
Email	hirsueki@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Koshikawa
Organization	Showa University
Division name	Department of Dermatology
Zip code	142-8666
Address	1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
TEL	03-3784-8556
Homepage URL
Email	skoshi@cnt.showa-u.ac.jp

Sponsor
Institute	AMED
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University
Address	1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
Tel	03-3784-8129
Email	m-rinri@ofc.showa-u.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	2020 Year 06 Month 05 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	Preinitiation
Date of protocol fixation	2020 Year 03 Month 30 Day
Date of IRB	2020 Year 05 Month 28 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2022 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Clinical information 1.Age, sex, height, weight, smoking status, medications, history, complications, allergic predisposition of the target patient 2. Diagnosis name, medical history, clinical symptoms, treatment content (steroid drug, immunosuppressant drug, ICI), progress of the original disease 3. Blood test findings: white blood cell count, lymphocyte count, CD4 count, CD8 count, platelet count, IgG level, hepatorenal function, LDH, electrolyte, HbA1c, CRP, KL6, SPA, SPD, beta D Glucan, BNPor NT proBNP, T SPOT, cytomegalovirus (CMV) antigen In particular, we will examine in detail the changes in white blood cell count, lymphocyte count, neutrophil / lymphocyte ratio, platelet count, and CRP before and after the onset of IRIS. Blood test: IL1 alpha, IL1ra, IL 2, IL 4, IL 5, IL 6, IL 7, IL 8, IL 10, IL 13, IL 15, IL 17 , IFN gamma, TNF alpha, G CSF, IP 10, sFasL, granulysin, TARC, CD4 number, CD8 number, Treg fraction. Saliva test: Viral DNA quantification (herpes virus) 4.Imaging findings: chest X ray, CT 5. Bacteriological examination findings 6. Non HIV IRIS diagnosis basis, time of onset, and treatment content 7. Non HIV IRIS outcome

Management information
Registered date	2020 Year 06 Month 01 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046341

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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