UMIN-CTR Clinical Trial

Basic information
Public title	Expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Acronym	Expression of antimicrobial protein
Scientific Title	Expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Scientific Title:Acronym	Expression of antimicrobial protein
Region	Japan

Condition
Condition	ulcerative colitis, familial adenomatous polyposis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To assess the expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Basic objectives2	Others
Basic objectives -Others	To assess the expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Key secondary outcomes

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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis or familial adenomatous polyposis
Key exclusion criteria	Patients who the doctor judged inadequate
Target sample size	50

Research contact person
Name of lead principal investigator	1st name KAZUHIRO Middle name Last name WATANABE
Organization	Tohoku University Hospital
Division name	SURGERY
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7205
Email	k-wata@surg.med.tohoku.ac.jp

Public contact
Name of contact person	1st name KAZUHIRO Middle name Last name WATANABE
Organization	Tohoku University Hospital
Division name	SURGERY
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7205
Homepage URL
Email	k-wata@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
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	Tohoku University Hospital
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-7205
Email	k-wata@surg.med.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	2019 Year 07 Month 24 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	Preinitiation
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aim of this study is to assess the expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis

Management information
Registered date	2018 Year 08 Month 31 Day
Last modified on	2019 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038747

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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