UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008223
Receipt No. R000009658
Scientific Title The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy: a prospective observation study.
Date of disclosure of the study information 2012/07/01
Last modified on 2017/06/26

* 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 The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy: a prospective observation study.
Acronym The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy.
Scientific Title The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy: a prospective observation study.
Scientific Title:Acronym The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy.
Region
Japan

Condition
Condition Solid tumor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop and validate a model using immature platelet fraction to predict the recovery from thrombocytopenia after chemotherapy.
Basic objectives2 Others
Basic objectives -Others Observation study
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The recovery from thrombocytopenia
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 1) Patients who have solid tumor.
2) Patients who are undergoing chemotherapy with myelosuppressive agents.
3) Patients who are over 18 years of age.
4) Patients who have given written informed consent.
Key exclusion criteria 1) Hemorrhagic and thrombotic disorders
2) Disseminated intravascular coagulation
3) Bone marrow failure
4) Secondary hematopoietic disorders
5) Secondary platelet aggregation
6) Patients considered ineligible for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Tamura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email ketamura@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emi Noguchi
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email enoguchi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Center for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine
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
2012 Year 07 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 Completed
Date of protocol fixation
2012 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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 Immature platelet fraction is measured during chmotherapy.

Management information
Registered date
2012 Year 06 Month 21 Day
Last modified on
2017 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.