UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The detection of immatire platelet fraction for predicting the recovery from thrombocytopenia after chemotherapy: a prospective observation study.
Title of the study (Brief title)	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	Kenji Tamura
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	ketamura@ncc.go.jp

Public contact
Name of contact person	Emi Noguchi
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009658