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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041798
Receipt No. R000047719
Scientific Title POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/15

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Basic information
Public title POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study
Acronym POKSTIC study
Scientific Title POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study
Scientific Title:Acronym POKSTIC study
Region
Japan

Condition
Condition Chronic Myeloid Leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We investigate clinical impact of polymorphisms of killer immunoglobulin-like receptor and human leukocyte antigen for treatment free remission in patients with chronic myeloid leukemia.
Basic objectives2 Others
Basic objectives -Others We investigate patients who were previously enrolled in three TKI discontinuation trials (DADI, DOMEST and first-line DADI).
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Polymorphisms of KIR for TFR
Key secondary outcomes Polymorphisms of HLA for TFR
Haplotypes (KIR and HLA) for TFR
Polymorphisms of KIR and features of anti-tumor immunity

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were previously enrolled in TKI discontinuation trials (DADI, DOMEST and first-line DADI) and regularly observed.

Patients who give informed consent.
Key exclusion criteria Patients who can not give informed consent.

Patients who were defined as appropriate by attending physician.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kimura
Middle name
Last name Shinya
Organization Saga University
Division name Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,
Zip code 859-8501
Address 5-1-1, Nabeshima Saga-city Saga, Japan
TEL 0952-34-2366
Email shkimu@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Ureshino
Middle name
Last name Hiroshi
Organization Saga University
Division name Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,
Zip code 859-8501
Address 5-1-1, Nabeshima Saga-city Saga, Japan
TEL 0952-34-2366
Homepage URL
Email sr0795@cc.saga-u.ac.jp

Sponsor
Institute Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University
Institute
Department

Funding Source
Organization Bristol Myers Squibb
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 Saga University
Address 5-1-1, Nabeshima, Saga-city, Saga, Japan
Tel 0952-34-2366
Email 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
2020 Year 09 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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 29 Day
Date of IRB
2020 Year 04 Month 06 Day
Anticipated trial start date
2020 Year 04 Month 06 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 09 Month 15 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047719

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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