UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034282 |
|---|---|
| Receipt number | R000039082 |
| Scientific Title | Prospective observational study of the complications related to totally implantable venous access ports (TIVAPs) in cancer patients |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2024/03/31 19:26:15 |
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Basic information
Public title
Prospective observational study of the complications related to totally implantable venous access ports (TIVAPs) in cancer patients
Acronym
Observational study of complications related to TIVAPs in cancer patients
Scientific Title
Prospective observational study of the complications related to totally implantable venous access ports (TIVAPs) in cancer patients
Scientific Title:Acronym
Observational study of complications related to TIVAPs in cancer patients
Region
| Japan |
Condition
Condition
Patients with cancer who has TIVAPs implanted by physicians in Department of Medical Oncology,Osaki Citizen Hospital and Tohoku University Hospital.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the frequency of complications related to TIVAPs in cancer patients and to investigate the risk factors of the complications.
Basic objectives2
Others
Basic objectives -Others
Another aim of this study is to examine the frequency of complications related to TIVAPs in cancer patients receiving home parenteral nutrition.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of the complications related to TIVAPs
Key secondary outcomes
Frequency of the complications related to TIVAPs in patients with home parenteral nutrition
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cancer who has TIVAPs implanted by physicians in Department of Medical Oncology, Osaki Citizen Hospital and Tohoku University Hospital.
Key exclusion criteria
Patients with active infection
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Chikashi |
| Middle name | |
| Last name | Ishioka |
Organization
Institute of Development, Aging and Cancer Tohoku University
Division name
Department of Clinical Oncology
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL
+81-22-717-8543
chikashi@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kawamura |
Organization
Institute of Development, Aging and Cancer Tohoku University
Division name
Department of Clinical Oncology
Zip code
9808575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL
+81-22-717-8543
Homepage URL
yoshifumi.kawamura.r2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaki Citizen Hospital(Perform TIVAPs placement)
Hitachi, Ltd.(Analyze anonymized data)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Tohoku University, 1-1, Seiryocyou, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
med-kenkyo@grp.tohoku.ac.jp
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
| 2018 | Year | 10 | 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
452
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients require providing written informed consent.
Clinical data is registered at the time of TIVAPs implantation, at the start of home parenteral nutrition, at the time of occurrence of complications and at the end of observation.
We calculate the frequency of complications related to TIVAPs and investigate the risk factors of the complications by multivariate analyses.
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039082
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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