UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028091
Receipt No. R000032161
Scientific Title Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies.
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies.
Acronym Relationship between the treatment in hematological malignancies and endothelial progenitor cells (EPC)
Scientific Title Clinical investigation for the establishment of predictive marker for therapy-related cardiovascular adverse events onset in hematologic malignancies.
Scientific Title:Acronym Relationship between the treatment in hematological malignancies and endothelial progenitor cells (EPC)
Region
Japan

Condition
Condition hematologic malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes of xanthine oxidase activity and the absolute number of EPC in peripheral blood before and after in each treatment against hematologic malignancies.
Basic objectives2 Others
Basic objectives -Others Relationship with cardiovascular adverse events onset
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between the changes of xanthine oxidase activity, the absolute number of EPC in peripheral blood and the cardiovascular adverse events onset
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients diagnosed with hematologic malignancies and who will be treated by the therapy which can cause cardiovascular adverse events onset at Akita university hospital.
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Kobayashi
Organization Akita University Graduate School of Medicine
Division name Department of Hematology, Nephrology, Rheumatology,
Zip code
Address 1-1-1 Hondo, Akita City, Akita, Japan
TEL 018-884-6116
Email takahiro@med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kobayashi
Organization Akita University Graduate School of Medicine
Division name Department of Hematology, Nephrology, Rheumatology,
Zip code
Address 1-1-1 Hondo, Akita City, Akita, Japan
TEL 018-884-6116
Homepage URL
Email takahiro@med.akita-u.ac.jp

Sponsor
Institute Department of Hematology, Nephrology, Rheumatology, Akita University Graduate School of Medicine.
Institute
Department

Funding Source
Organization Department of Hematology, Nephrology, Rheumatology, Akita University Graduate School of Medicine.
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 07 Month 06 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
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate the clinical data which can be concerned with cardiovascular adverse events onset for example basic physical information and comorbidities and laboratory abnormalities

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.