Unique ID issued by UMIN | UMIN000040607 |
---|---|
Receipt number | R000046341 |
Scientific Title | Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers. |
Date of disclosure of the study information | 2020/06/05 |
Last modified on | 2023/06/04 20:36:56 |
Establishment of the concept of immune reconstitution syndrome not related to HIV infection with study for development of biomarkers
Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers.
Establishment of the concept of non-HIV immune reconstitution inflammatory syndrome (IRIS) with study for development of biomarkers.
Establishment of the concept of non-HIV IRIS with study for development of biomarkers.
Japan |
immune reconstitution inflammatory syndrome (IRIS)
Pneumology | Clinical immunology | Infectious disease |
Dermatology |
Others
NO
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.
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.
Exploratory
Pragmatic
Not applicable
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.
Neutrophil / lymphocyte ratio at the start of treatment of the primary disease and at the onset of IRIS event
Observational
18 | years-old | <= |
90 | years-old | > |
Male and Female
Patients with drug-induced hypersensitivity syndrome, collagen disease / autoimmune disease before the start of immunomodulators, or patients who meet the diagnostic criteria for IRIS.
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.
120
1st name | Hirohiko |
Middle name | |
Last name | Sueki |
Showa University
Department of Dermatology
142-8666
1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
03-3784-8556
hirsueki@med.showa-u.ac.jp
1st name | Sachiko |
Middle name | |
Last name | Koshikawa |
Showa University
Department of Dermatology
142-8666
1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
03-3784-8556
skoshi@cnt.showa-u.ac.jp
AMED
AMED
Japanese Governmental office
Showa University
1-5-8, Hatanodei, Shinagawa-ku, Tokyo 142-8666
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
NO
2020 | Year | 06 | Month | 05 | Day |
Unpublished
124
2023 | Year | 06 | Month | 04 | Day |
Delay expected |
Due to the unachieved data analyses.
Enrolling by invitation
2020 | Year | 03 | Month | 30 | Day |
2020 | Year | 05 | Month | 28 | Day |
2020 | Year | 06 | Month | 08 | Day |
2023 | Year | 03 | Month | 15 | Day |
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
2020 | Year | 06 | Month | 01 | Day |
2023 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046341