UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038710 |
|---|---|
| Receipt number | R000043925 |
| Scientific Title | Feasibility study of target capture RNA-sequencing for B-cell acute lymphoblastic leukemia |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2025/06/02 09:38:08 |
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Basic information
Public title
Feasibility study of target capture RNA-sequencing for B-cell acute lymphoblastic leukemia
Acronym
Feasibility study of target capture RNA-sequencing for B-cell acute lymphoblastic leukemia(NHOH-RNAseq-BALL)
Scientific Title
Feasibility study of target capture RNA-sequencing for B-cell acute lymphoblastic leukemia
Scientific Title:Acronym
Feasibility study of target capture RNA-sequencing for B-cell acute lymphoblastic leukemia(NHOH-RNAseq-BALL)
Region
| Japan |
Condition
Condition
B-cell Acute Lymphoblastic Lekaemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Construction the framework for target capture RNA-sequencing in clinical setting
Basic objectives2
Others
Basic objectives -Others
Evaluation the effectiveness and problems of target capture RNA-sequencing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of subtype detection by target capture RNA-sequencing within 60 days
Key secondary outcomes
Frequency of subtype detection by cytogenetic testing
Evaluating the time period to returning a report
Consistency with the results of clinical examination (RT-PCR or FISH)
Consistency with the results of other methods (RNA-seq, whole genome sequencing, target capture DNA-seq, RT-PCR)
Evaluating costs of target capture RNA-seq in clinical settings
Frequency of the patients who received allogeneic transplantation
Frequency of the patients who received tyrosine kinase inhibitor
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) Newly diagnosed, relapsed, or refractory patients who diagnosed as B-ALL (NOS) or B-ALL with recurrent genetic abnormalities by WHO classification 2016
(2) Patients whose written consent was obtained within a week from diagnosis
(3) Patients who agreed to submit a specimen containing more than 10% of tumor within a week from study entry
Key exclusion criteria
Inappropriate patients judged by principal investigator or co-investigator
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Yasuda |
Organization
Nagoya Medical Center
Division name
Clinical Research Center
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku Nagoya, Aichi 460-0001, Japan
TEL
052-951-1111
takahiko.yasuda@nnh.go.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Hirano |
Organization
Nagoya Medical Center
Division name
Hematology Department
Zip code
460-0001
Address
4-1-1 Sannomaru, Naka-ku Nagoya, Aichi 460-0001, Japan
TEL
052-951-1111
Homepage URL
hirano.daiki.jq@mail.hosp.go.jp
Sponsor or person
Institute
Nagoya Medical Center
Institute
Department
Personal name
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 IRB
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo 152-8621, Japan
Tel
03-5712-5050
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
| 2019 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Not available (protocol not published online)
Publication of results
Unpublished
Result
URL related to results and publications
Results not yet available
Number of participants that the trial has enrolled
94
Results
The main results are currently under analysis and will be published in due course.
Results date posted
| 2025 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were diagnosed with B-cell acute lymphoblastic leukemia (B-ALL).
Participant flow
After obtaining informed consent, samples were collected and subjected to target capture RNA sequencing. Molecular subtyping was performed based on the sequencing data, and the results were returned to the treating physician. Feasibility was assessed by documenting the completion of each step.
Adverse events
No adverse events related to this study were observed.
Outcome measures
The primary outcome measure was the success rate of molecular subtyping using target capture RNA sequencing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Integrated analysis of subtype, patient characteristics and clinical examination
Search for co-existing genomic alterations in specific subtypes
Identification of novel subtypes by integrating analysis of gene expression and genomic alterations
Diagnosis of Ph-like ALL by target capture RNA-sequencing
Management information
Registered date
| 2019 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043925
