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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040607 |
Receipt No. | 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 | 2020/06/01 |
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 |
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Condition | |||||
Condition | immune reconstitution inflammatory syndrome (IRIS) | ||||
Classification by specialty |
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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 | |
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Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | AMED
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Institute | |
Department |
Funding Source | |
Organization | AMED |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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 |
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Last modified on |
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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 | |
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Research case data | |
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