UMIN-CTR Clinical Trial
| 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 |
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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
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
skoshi@cnt.showa-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
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
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
124
Results
Results date posted
| 2023 | Year | 06 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to the unachieved data analyses.
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
Enrolling by invitation
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
| 2023 | Year | 03 | Month | 15 | 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
| 2023 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046341
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/12/05 | 22ek0410068h0003研究開発計画書(末木 博彦_昭和大 ?)_?2? 11.29..docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
