UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014794 |
|---|---|
| Receipt number | R000017198 |
| Scientific Title | Optimization of blood examination from central venous ports in cancer patients. |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2016/09/13 18:38:52 |
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Basic information
Public title
Optimization of blood examination from central venous ports in cancer patients.
Acronym
Optimization of blood examination from central venous ports in cancer patients.
Scientific Title
Optimization of blood examination from central venous ports in cancer patients.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akihito Tsuji |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
t-kotake@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kotake |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
Homepage URL
t-kotake@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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)
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
| 2014 | Year | 08 | Month | 15 | 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
| 2014 | Year | 08 | Month | 07 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017198
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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