UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058281 |
|---|---|
| Receipt number | R000066626 |
| Scientific Title | Establishment and functional characterization of human lymph node organoids derived from palatine tonsil and adenoid tissues |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/25 22:26:14 |
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Basic information
Public title
A study using miniature immune organs made from throat cells to explore how our immune system works
Acronym
Reconstitution of immune responses using throat-derived cells
Scientific Title
Establishment and functional characterization of human lymph node organoids derived from palatine tonsil and adenoid tissues
Scientific Title:Acronym
Establishment and characterization of human lymph node organoids
Region
| Japan |
Condition
Condition
Palatine tonsillar hypertrophy, Adenoid hypertrophy, Chronic tonsillitis (including IgA nephropathy)
Classification by specialty
| Nephrology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In vitro modeling of human immune responses using palatine tonsil and adenoid-derived cells to reveal lymphocyte activation mechanisms
Basic objectives2
Others
Basic objectives -Others
To recapitulate germinal center B cell formation, T cell activation, antibody affinity maturation, and class switching from human B cells, and to elucidate the mechanisms of their activation and differentiation into memory B cells and plasma cells
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Phenotypic analysis of tissue-resident immune cells and evaluation of their proliferation and aggregate formation in vitro
Key secondary outcomes
Establishment of an organoid-based platform for recapitulating immune activation and differentiation
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with palatine tonsillar hypertrophy, chronic tonsillitis (including IgA nephropathy), or adenoid hypertrophy at the Department of Otorhinolaryngology - Head and Neck Surgery, Kyushu University Hospital or collaborating institutions, and who have undergone palatine tonsillectomy or adenoidectomy between the date of research approval and March 31, 2030.
2.Patients (or their legal representatives) who fully understand the research plan and are capable of providing informed consent.
Key exclusion criteria
1.Patients with malignant tumors or those undergoing surgery due to suspected malignancy.
2.Patients whom the investigator deems unsuitable for inclusion in the study for any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Murakami |
Organization
Kyushu University Hospital
Division name
Otorhinolaryngology -
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926425668
murakami.daisuke.181@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Murakami |
Organization
Kyushu University Hospital
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926425668
Homepage URL
murakami.daisuke.181@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Daisuke Murakami
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Committee of the Medical Departments and Hospital, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
Tel
+81-92-642-5082
ijkseimei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24353
Org. issuing International ID_1
Ethics Committees of Kyushu University Hospital and Medical Institutions
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）、千鳥橋病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study using human specimens.
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066626
