UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037535 |
|---|---|
| Receipt number | R000042793 |
| Scientific Title | J-SKI |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/02/07 09:44:32 |
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Basic information
Public title
Multi-Institutional Collaborative Study for Estimating the Persistence of Treatment Free Remission in Chronic Myeloid Leukemia after Stopping Tyrosine Kinase Inhibitor in Japan
Acronym
J-SKI
Scientific Title
J-SKI
Scientific Title:Acronym
J-SKI
Region
| Japan |
Condition
Condition
CML (chronic myeloid leukemia)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of J-SKI, which is a prospective observational study in chronic myeloid leukemia after stopping tyrosine kinase inhibitor in Japan is to determine the treatment free remission (TFR) in long term follow-up and to determine clinical factors that predict successful TFR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
TFR rate at 5-years after stopping TKI
Key secondary outcomes
TFR rate at 10-years after stopping TKI
Estimated Treatment Free Survival (TFS) or Progression Free Survival (PFS) to AP or BC after stopping TKI
Cumulative Re-MMR rate after retreatment with TKI in patients who lost TFR
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
CML with major BCR-ABL
1)All patients with CML who will stop TKI because of any reason in general practice or have stopped TKI in clinical trials or in general practice regardless of thee results of TFR.
3) Written informed consent on documents fro the subject or a legal guardian if a patient is a minor
Key exclusion criteria
1) Patients who can not provide clinical information and data before and after stopping TKI or after re-treatment by TKI
2) Other, patients whom the investigator considers to be unsuitable for participation in the study.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Takahashi |
Organization
Akita University School of Medicine
Division name
Department of Hematology, Nephrology, and Rheumatology
Zip code
010-8543
Address
44-2,Hasunuma Hiroomote, Akita-shi,Akita,010-8543,Japan
TEL
018-834-1111
naotot@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Takahashi |
Organization
Akita University School of Medicine
Division name
Department of Hematology, Nephrology, and Rheumatology
Zip code
010-8543
Address
44-2,Hasunuma Hiroomote, Akita-shi,Akita,010-8543,Japan
TEL
018-834-1111
Homepage URL
naotot@doc.med.akita-u.ac.jp
Sponsor or person
Institute
THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department
Personal name
Funding Source
Organization
THE JAPANESE SOCIETY OF HEMATOLOGY
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University IRB
Address
5-1-1,Nabeshima,Saga-shi,Saga, 849-8501,Japan
Tel
0952-34-3357
kenkyu-shinsei@ml.cc.saga-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
| 2019 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 09 | Month | 30 | Day |
Other
Other related information
Study design: Prospective multi-institutional collaborative observational study.
Recruitment method: All patients with CML-CP who fit inclusion criteria in an institution of JSH members.
Study period: from approval date by IRB to 31-Mar.-2024
Management information
Registered date
| 2019 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042793
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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