UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028506
Receipt number R000032408
Scientific Title Prospective study for investigating the clinical course of Crohn's disease
Date of disclosure of the study information 2017/08/31
Last modified on 2018/03/08 16:35:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prospective study for investigating the clinical course of Crohn's disease

Acronym

Prospective study for investigating the clinical course of Crohn's disease

Scientific Title

Prospective study for investigating the clinical course of Crohn's disease

Scientific Title:Acronym

Prospective study for investigating the clinical course of Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the recent clinical course of Crohn's disease and factors that affect the surgery, emergency hospitalization, clinical relapse and Quality of life.

Basic objectives2

Others

Basic objectives -Others

Image diagnosis of Crohn's disease and its relationship with clinical features

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cumulative non-operative rate
Cumulative non-emergency hospitalization rate

Key secondary outcomes

Clinical factors on cumulative nonoperative rate,cumulative non-emergency hospitalization rate


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as Crohn's disease.

Key exclusion criteria

1.Patient without the ability for self-judgment.
2.Medical doctors decided the patients are inapropriate.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Watanabe

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho,Showa-ku,Nagoya

TEL

052-744-2172

Email

osa-wata@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Nishikawa

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 Tsurumai-cho,Showa-ku,Nagoya

TEL

052-744-2172

Homepage URL


Email

t.nishikawa@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine

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


Address


Tel


Email



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

2017 Year 08 Month 31 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

2017 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design:Case series study
Measurements;
General information(age,gender,height,body weight,symptom,disease duration,past history,operation history,medication,family history,physical findings),Treatment,Image findings,Endoscopic findings,Capsule endoscopic findings,Endoscopic treatment,histopathological findings,blood exam(red blood cells, white blood cells, platelets, albumin,total cholesterol,hepatobiliary system enzyme, lactase dehydrogenase,amylase, C-reactive protein, blood urea nitrogen, creatinine, erythrocyte sedimentation rate,blood,concentration of infliximab),CDAI(Crohn's Disease Activity Index),IBDQ(Inflammatory Bowel Disease Questionnaire)


Management information

Registered date

2017 Year 08 Month 02 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name