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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030257
Receipt No. R000034555
Scientific Title Significance of breakpoint in the BCR gene in Ph+ALL
Date of disclosure of the study information 2017/12/11
Last modified on 2019/12/06

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Basic information
Public title Significance of breakpoint in the BCR gene in Ph+ALL
Acronym Breakpoint of BCR in Ph+ALL
Scientific Title Significance of breakpoint in the BCR gene in Ph+ALL
Scientific Title:Acronym Breakpoint of BCR in Ph+ALL
Region
Japan

Condition
Condition Philadelphia chromosome-positve acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identify the impact of BCR breakpoint in Ph+ALL
Basic objectives2 Others
Basic objectives -Others Pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lineage of blood cells which expressed BCR-ABL chimeric gene
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Ph+ALL patients who agreed the use of perserved samples
2. Ph+ALL patients who underwent allogeneic hematopoietic cell transplantation and whose data were registered in the TRUMP database
Key exclusion criteria Patients who refused the use of their samples and/or data
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Nishiwaki
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya 4668560, Japan
TEL 052-744-2942
Email n-3104@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Nishiwaki
Organization Nagoya Univiersity Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya 4668560, Japan
TEL 052-744-2942
Homepage URL
Email n-3104@med.nagoya-u.ac.jp

Sponsor
Institute Center for Advanced Medicine and Clinical Research, Nagoya University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
Address
Tel
Email

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
2017 Year 12 Month 11 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
2019 Year 05 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Basic science using preserved samples and outcome analyses using TRUMP database

Management information
Registered date
2017 Year 12 Month 04 Day
Last modified on
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034555

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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