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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043417
Receipt No. R000049573
Scientific Title Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Date of disclosure of the study information 2021/02/22
Last modified on 2021/02/22

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Basic information
Public title Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Acronym Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Scientific Title Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Scientific Title:Acronym Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Region
Japan

Condition
Condition right-side colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the peak of venous phase enhancement can be appropriately scanned by low dose monitoring for right-side colon cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CT value in venous phase
Key secondary outcomes Timing of venous scan
CT value of parenchymal organs
Patient characteristics

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 CT scanned with patient-specific timing
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 who are performed 3D-CT for right-side colon cancer
Key exclusion criteria Previous surgical history for gastroenterological diseases
Inappropriate for enrollment
Informed consent is not obtained
Iodine allergy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address S1 W16, Chuo-ku, Sapporo
TEL 011-611-2111
Email itakemasa@sapmed.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Hamabe
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address S1 W16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email ahamabe@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sapporo medical university hospital institutional review board
Address 291, South1 West16, Chuo-ku, Sapporo, Hokkaido
Tel 011-611-2111
Email ji-rskk@sapmed.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
2021 Year 02 Month 22 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 02 Day
Date of IRB
2020 Year 01 Month 14 Day
Anticipated trial start date
2020 Year 01 Month 16 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 22 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049573

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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