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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046100
Receipt No. R000052624
Scientific Title TNF-a expression by myeloid cells in ascites regulate colorectal cancer
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/17

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Basic information
Public title TNF-a expression by myeloid cells in ascites regulate colorectal cancer
Acronym TNF-a expression by myeloid cells in ascites regulate colorectal cancer
Scientific Title TNF-a expression by myeloid cells in ascites regulate colorectal cancer
Scientific Title:Acronym TNF-a expression by myeloid cells in ascites regulate colorectal cancer
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The role of inflammatory cells in ascites in patients with colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes TNF-a expression by myeloid cells in ascites
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Colorectal cancer surgery
Interventions/Control_2 inguinal hernia surgery
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Cases of colorectal cancer or inguinal hernia repair at Juntendo University
Key exclusion criteria Double cancer
Diabetes with poor control
Uncontrolled liver cirrhosis, renal failure, heart failure
Psychosis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Tsuchiya
Organization Juntendo University
Division name Department of Coloproctological Surgery
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku
TEL 0338133111
Email yutsuchi@juntendo.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Tsuchiya
Organization Juntendo colorectal teams study of ascites
Division name Department of Coloproctological Surgery
Zip code 1138421
Address 2-1-1
TEL 0338133111
Homepage URL
Email yutsuchi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics committee of Juntendo University
Address 2-1-1 Hongo, Bunkyo-ku
Tel 0338133111
Email yutsuchi@juntendo.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 11 Month 17 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
2016 Year 10 Month 20 Day
Date of IRB
2016 Year 10 Month 20 Day
Anticipated trial start date
2016 Year 10 Month 20 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 11 Month 17 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052624

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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