UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062174 |
|---|---|
| Receipt number | R000071141 |
| Scientific Title | A Multicenter Observational Study to Characterize Clonal Hematopoiesis in Long-Term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/08 16:56:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multicenter Observational Study to Characterize Clonal Hematopoiesis in Long-Term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation
Acronym
A Multicenter Observational Study to Characterize Clonal Hematopoiesis in Long-Term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation
Scientific Title
A Multicenter Observational Study to Characterize Clonal Hematopoiesis in Long-Term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
A Multicenter Observational Study to Characterize Clonal Hematopoiesis in Long-Term Survivors After Allogeneic Hematopoietic Stem Cell Transplantation
Region
| Japan |
Condition
Condition
Hematologic diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To characterize clonal hematopoiesis and investigate its associations with transplant-related factors and post-transplant complications in long-term survivors after allogeneic hematopoietic stem cell transplantation.
Basic objectives2
Others
Basic objectives -Others
Characterization of clonal hematopoiesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of clonal hematopoiesis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who survived for at least 2 years after allogeneic hematopoietic stem cell transplantation, remained in complete remission, and provided written informed consent.
Key exclusion criteria
Patients with a history of relapse of the primary disease, suspected mixed chimerism, or those considered unsuitable for the study by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Imahashi |
Organization
NHO Nagoya Medical Center
Division name
Hematology
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi
TEL
0529511111
imahashi.nobuhiko.wf@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Imahashi |
Organization
NHO Nagoya Medical Center
Division name
Hematology
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi
TEL
0529511111
Homepage URL
imahashi.nobuhiko.wf@mail.hosp.go.jp
Sponsor or person
Institute
NHO Nagoya Medical Center
Institute
Department
Personal name
Nobuhiko Imahashi
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Institutional Review Board for Clinical Research
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo, Japan
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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 | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes.
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071141
