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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043826
Receipt No. 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 2021/04/02

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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
Institute Nagoya University
Institute
Department

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
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
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
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.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


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