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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038710
Receipt No. 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 2019/11/29

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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
Email 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
Email hirano.daiki.jq@mail.hosp.go.jp

Sponsor
Institute Nagoya Medical Center
Institute
Department

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
Email 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
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
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
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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