UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039899 |
|---|---|
| Receipt number | R000045505 |
| Scientific Title | Multicenter prospective observational study on minimal residual disease of ALL after allogeneic transplantation using circulating cell-free tumor DNA KSGCT1901(ctALL) |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2021/04/03 08:39:35 |
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Basic information
Public title
Multicenter prospective observational study on minimal residual disease of ALL after allogeneic transplantation using circulating cell-free tumor DNA KSGCT1901(ctALL)
Acronym
Prospective study on MRD of ALL after transplant using ctDNA, KSGCT1901(ctALL)
Scientific Title
Multicenter prospective observational study on minimal residual disease of ALL after allogeneic transplantation using circulating cell-free tumor DNA KSGCT1901(ctALL)
Scientific Title:Acronym
Prospective study on MRD of ALL after transplant using ctDNA, KSGCT1901(ctALL)
Region
| Japan |
Condition
Condition
Acute lymphocytic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the usefulness of predicting relapse of ALL after transplant using ctDNA monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year cumulative incidence of ALL relapse
Key secondary outcomes
One-year overall survival,
Somatic gene mutation, gene expression and immune cell profile at initial diagnosis and relapse
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients age >= 16 years
2) Precursor Lymphoid neoplasms, Chronic myeloid leukeamia, BCR-ABL1-positive in blastic phase (not including myeloid crisis), and mixed-phenotype acute leukeamia with t(9;22)
3) No limit on the disease stage or chemosensitivity at the time of transplant
4) Patients in which a high-quality sample with a tumor volume of 20% or more (at the time of initial diagnosis or relapse) is available.
5) Patients who may undergo allogeneic transplantation at the time of registration.
6)Patients who were informed and concented
Key exclusion criteria
Patients who are otherwise classified as unfit by the attending physicians for this research.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Okamoto |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
186-0004
Address
Tokyo
TEL
042-505-4251
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishii |
Organization
Jikei University School of Medicine
Division name
Division of Clinical Oncology and Hematology
Zip code
105-8471
Address
3-19-18 Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
ksgctdc@ksgct.net
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University School of Medicine
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
| 2020 | Year | 03 | Month | 23 | 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
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:prospective observational study
Under the collection of cases at multi-institutional collaboration study
Management information
Registered date
| 2020 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045505
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
