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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011798
Receipt No. R000013764
Scientific Title Pharmacokinetic, pharmacodynamic and pharmacogenetic research on biomarkers in cancer patients with special response to pharmacological therapy
Date of disclosure of the study information 2013/10/01
Last modified on 2020/03/23

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Basic information
Public title Pharmacokinetic, pharmacodynamic and pharmacogenetic research on biomarkers in cancer patients with special response to pharmacological therapy
Acronym A translational research in cancer patients with special response to pharmacological therapy
Scientific Title Pharmacokinetic, pharmacodynamic and pharmacogenetic research on biomarkers in cancer patients with special response to pharmacological therapy
Scientific Title:Acronym A translational research in cancer patients with special response to pharmacological therapy
Region
Japan

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

Objectives
Narrative objectives1 To identify novel biomarkers in cancer patients with special response to pharmacological therapy
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Not applicable
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Blood sampling
Interventions/Control_2 Patients may have additional sampling of specimens only if necessary.

e.g. bone marrow, urine, cerebrospinal fluid, body cavity fluid, skin, lymph node, saliva, oral mucous membrane, and/or tumor tissue
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) Pathologically proven malignant tumor
2) Administration of pharmacological therapy, including the planning phase
3) Aged 16 years or older at the time of enrollment
4) Written informed consent
5) Feasible for sampling adequate specimens
Key exclusion criteria Judged to be inadequate for enrollment by the investigator
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5820
Email hminami@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Imamura
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5820
Homepage URL
Email yimamura@med.kobe-u.ac.jp

Sponsor
Institute Medical Oncology / Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization Medical Oncology / Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 10 Month 01 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
2013 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 18 Day
Last modified on
2020 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013764

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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