UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008223 |
|---|---|
| Receipt number | 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 09:12:11 |
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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
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
enoguchi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009658
