UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The predictive value of measuring immature platelet fraction (IPF) in the recovery from thrombocytopenia caused by chemotherapy in lung cancer patients
Title of the study (Brief title)	The predictive value of immature platelet fraction (IPF) in the recovery from thrombocytopenia in lung cancer chemotherapy
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	the usefulness of measuring immmature platelet fraction as the predictive factor for the recovery from thronbocytopenia in lung cancer chemotherapy
Basic objectives2	Others
Basic objectives -Others	the acuracy of predicting to recover from thrombocytopenia
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	recovery from thronbocytopenia
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	lung cancer patients recieved chemotherapy
Key exclusion criteria	lung cancer patients not recieved chemotherapy
Target sample size	250

Research contact person
Name of lead principal investigator	Shigeaki Ogura
Organization	Hokkaido Medical Center, Natinal Hospital Organaizetion
Division name	Department of Respirology
Address	Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-8111
Email

Public contact
Name of contact person	Shigeaki Ogura
Organization	Hokkaido Medical Center
Division name	Department of Respirology
Address	Yamanote 5-jo 7-chome, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-8111
Homepage URL
Email

Sponsor
Institute	Hokkaido Medical Center, Natinal Hospital Organaizetion
Institute
Department

Funding Source
Organization	Hokkaido Medical Center, Natinal Hospital Organaizetion
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Asahikawa Medical Center, Natinal Hospital Organaizetion
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	北海道医療センター（北海道）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 05 Month 25 Day
Anticipated trial start date	2011 Year 05 Month 30 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	twice a week, platelet and IPF are measured at least during chemotherapy. If Grade 3 thrombocytopenia occures, platelet and IPF are measured every two days until the recovery.

Management information
Registered date	2011 Year 06 Month 19 Day
Last modified on	2019 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006843