UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041268
Receipt number R000047115
Scientific Title A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/31 16:33:35

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Basic information

Public title

A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease

Acronym

comprehensive sampling in patients with autoimmune and immune related disease

Scientific Title

A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease

Scientific Title:Acronym

comprehensive sampling in patients with autoimmune and immune related disease

Region

Japan


Condition

Condition

Patients with autoimmune/immune-related diseases such as ulcerative colitis, Crohn's disease, Bechet disease, immune-check point inhibitor related colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate biomarkers applicable to daily medical care by comprehensive sampling from patients with autoimmune and immune related diseases.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Expression of inflammatory cytokines in the intestinal tract, analysis of intestinal bacterial flora, measurement of fecal metabolites, identification of disease susceptibility genes

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who meet the diagnostic criteria for each disease
2. Patients who obtained written consent

Key exclusion criteria

1. Patients who have not confirmed the diagnosis
2. Patients who do not get written consent
3. Patients who the doctor judges as inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Nakase

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8543

Address

S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan

TEL

0116112111

Email

hiropynakase@gmail.com


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Yokoyama

Organization

Sapporo Medical University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8543

Address

S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan

TEL

0116112111

Homepage URL


Email

yoshi_yokoyamaa@yahoo.co.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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 School of Medicine

Address

S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan

Tel

0116112111

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

2020 Year 08 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

Open public recruiting

Date of protocol fixation

2019 Year 09 Month 12 Day

Date of IRB

2019 Year 09 Month 12 Day

Anticipated trial start date

2019 Year 09 Month 12 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2020 Year 07 Month 31 Day

Last modified on

2020 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047115


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name