UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061446 |
|---|---|
| Receipt number | R000070198 |
| Scientific Title | Development of patient registry and biorepository to establishment of standard therapy for histiocytosis |
| Date of disclosure of the study information | 2026/05/04 |
| Last modified on | 2026/05/03 12:44:42 |
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Basic information
Public title
Development of patient registry and biorepository to establishment of standard therapy for histiocytosis
Acronym
Histiocytosis Registry Study
Scientific Title
Development of patient registry and biorepository to establishment of standard therapy for histiocytosis
Scientific Title:Acronym
Histiocytosis Registry & Biorepository Study
Region
| Japan |
Condition
Condition
histiocytosis
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to systematically collect clinical information on histiocytosis, including presentation, diagnosis, treatment, and outcomes, to clarify the real-world disease characteristics and improve clinical practice. In addition, biological specimens such as tissue, blood, and bone marrow will be stored to support future genetic analyses and centralized pathological review.
Basic objectives2
Others
Basic objectives -Others
Establishing a research infrastructure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Collection of clinical information including diagnosis, treatment, clinical course, and outcomes
Storage of tissue, blood, and bone marrow specimens
DNA extraction and comprehensive genomic analysis including NGS
Centralized pathological review
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with histiocytosis based on pathological examination, including suspected cases.
All age groups, all histiocytic disorders, with no restriction on the date of diagnosis.
Patients who have been cured or who are deceased are also eligible.
2) Patients who have provided written informed consent to participate in the study
Key exclusion criteria
Patients who are judged by the investigators to be inappropriate for inclusion in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Sato |
Organization
The Institute of Medical Science Research Hospital, The University of Tokyo
Division name
Department of Hematology and Oncology
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
+81-3-5449-5542
akisato@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Sato |
Organization
The Institute of Medical Science Research Hospital, The University of Tokyo
Division name
Department of Hematology and Oncology
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
+81-3-5448-5542
Homepage URL
https://histio.jp/
histio@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The Institute of Medical Science Research Hospital, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The 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
The First Ethics Committee of the Institute of Medical Science, The University of Tokyo
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
Tel
+81-3-6409-2035
ken-rin@ims.u-tokyo.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
| 2026 | Year | 05 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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 a prospective multicenter observational registry collecting clinical data and biospecimens from patients with histiocytic disorders. Clinical information, imaging data, and pathological samples are collected at diagnosis and during follow up according to standardized procedures. Extracted DNA is subjected to immunohistochemistry and targeted gene panel sequencing to analyze associations with treatment response and prognosis.
Management information
Registered date
| 2026 | Year | 05 | Month | 03 | Day |
Last modified on
| 2026 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070198
