UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043826
Receipt number R000049975
Scientific Title Usefulness of LRG for predicting the activity of inflammatory bowel disease
Date of disclosure of the study information 2021/04/03
Last modified on 2022/10/02 18:20:13

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Basic information

Public title

Usefulness of LRG for predicting the activity of inflammatory bowel disease

Acronym

Usefulness of LRG for predicting IBD activity

Scientific Title

Usefulness of LRG for predicting the activity of inflammatory bowel disease

Scientific Title:Acronym

Usefulness of LRG for predicting IBD activity

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

By assessing the relationship between LRG and IBD clinical symptoms and endoscopic findings, we will clarify whether LRG can predict IBD activity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Whether LRG can predict IBD activity

Key secondary outcomes

Whether LRG can predict the therapeutic effect and prognosis of IBD


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with inflammatory bowel disease

Key exclusion criteria

Patients under 15 years
Contraindicated patients for endoscopy
Patients with autoimmune diseases other than inflammatory bowel disease
Patients that the doctor deems inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masanao
Middle name
Last name Nakamura

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

466-8560

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-741-2111

Email

makamura@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Kawamura

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

466-8560

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-741-2111

Homepage URL


Email

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


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya University

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

Nagoya University Hospital ethics committee

Address

65 Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan

Tel

052-741-2111

Email

ethics@med.nagoya-u.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 04 Month 03 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

115

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

Completed

Date of protocol fixation

2020 Year 06 Month 25 Day

Date of IRB

2017 Year 10 Month 12 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2022 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluate the relationship between clinical symptoms and endoscopic findings of LRG and IBD


Management information

Registered date

2021 Year 04 Month 02 Day

Last modified on

2022 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name