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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034282
Receipt No. 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 2019/09/27

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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 370

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
Email 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
Email yoshifumi.kawamura.r2@dc.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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
Email 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
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 Enrolling by invitation
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
2021 Year 09 Month 30 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
2019 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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