UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimization of blood examination from central venous ports in cancer patients.
Title of the study (Brief title)	Optimization of blood examination from central venous ports in cancer patients.
Region	Japan

Condition
Condition	Patients with solid tumors
Classification by specialty	Hematology and clinical oncology Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Determine the recommended volume for blood drawn from CV port in step1 and evaluate the usefulness of blood collection from CV port with the recommended discard volume in step2.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to compare laboratory results of blood samples drawn from central venous port systems with the results from venipuncture
Key secondary outcomes	safety for blood collection from CV port

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	blood collection from CV port blood collection from venipuncture
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written informed consent 2) Decision of suitableness by principal investigator 3) Patients with chemotherapy for solid tumor 4) Patients enabling blood collection from venipuncture 5) Patients enabling blood collection from CV ports 6) Age >= 20 years 7) ECOG performance status of 0,1
Key exclusion criteria	1) Decision of unsuitableness by principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Akihito Tsuji
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Email	t-kotake@kcho.jp

Public contact
Name of contact person	Takeshi Kotake
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Homepage URL
Email	t-kotake@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 07 Day
Anticipated trial start date	2014 Year 08 Month 18 Day
Last follow-up date	2014 Year 10 Month 15 Day
Date of closure to data entry	2014 Year 10 Month 15 Day
Date trial data considered complete	2014 Year 10 Month 15 Day
Date analysis concluded	2014 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 08 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017198