UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033975
Receipt number R000038747
Scientific Title Expression of antimicrobial protein in patients with ulcerative colitis or familial adenomatous polyposis
Date of disclosure of the study information 2019/07/24
Last modified on 2023/09/04 10:39:15

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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 or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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

No longer recruiting

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2019 Year 08 Month 01 Day

Anticipated trial start date

2019 Year 08 Month 10 Day

Last follow-up date

2028 Year 10 Month 01 Day

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

2023 Year 09 Month 04 Day



Link to view the page

Value
https://center6.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