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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040340
Receipt No. R000046033
Scientific Title Exploratory study to identify salivary biomarkers reflecting temporal disease activity in patients with Crohn's disease
Date of disclosure of the study information 2021/07/01
Last modified on 2020/05/08

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Basic information
Public title Exploratory study to identify salivary biomarkers reflecting temporal disease activity in patients with Crohn's disease
Acronym Exploratory study to identify salivary biomarkers reflecting temporal disease activity in patients with Crohn's disease
Scientific Title Exploratory study to identify salivary biomarkers reflecting temporal disease activity in patients with Crohn's disease
Scientific Title:Acronym Exploratory study to identify salivary biomarkers reflecting temporal disease activity in patients with Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will search for salivary biomarkers that reflect the disease activity of Crohn's disease by obtaining saliva, blood and serum of Crohn's disease patients and healthy subjects over time for statistical analysis of their correlations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of disease activity of Crohn's disease by saliva test
The saliva test and the CDAI score will be tracked longitudinally to evaluate the correlation of each. By using blood tests together, biomarkers of inflammation that can be reflected in saliva tests will be searched. In addition, the specificity of saliva test reflecting the disease activity of Crohn's disease is also evaluated by setting control group having no systemic disease..
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Intra-oral condition
Patients who meet both the following criteria for caries and periodontal disease:
Caries: Having experienced caries treatment and having at least one tooth restoration due to caries.
It does not matter whether it is an untreated tooth at the time of registration
Periodontal disease: Patients who have a periodontal pocket of 4 mm or more at one or more places in the periodontal examination.

Crohn's disease patients
Patients who have been diagnosed with Crohn's disease of both small and large intestine at the Department of Gastroenterology, Tohoku University Hospital and who regularly visit the hospital and who have been diagnosed with the above oral conditions by the Department of Conservative Dentistry.

Health patients
Patients who have visited the Tohoku University Hospital Department of Conservative Dentistry and have been diagnosed with the above oral conditions and have no systemic disease.
Key exclusion criteria Patients using colostomy.
If it seems difficult to comply with protocol treatment due to medical or psychological abnormalities.
the doctor in charge determines that it is inappropriate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Saito
Organization Tohoku University Graduate School of Dentistry
Division name Division of Operative Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba, Sendai 980-8575, Miyagi
TEL 022-717-8343
Email mssaito@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Yahata
Organization Tohoku University Graduate School of Dentistry
Division name Division of Operative Dentistry
Zip code 980-8575
Address 4-1, Seiryo-machi, Aoba, Sendai 980-8575, Miyagi
TEL 022-717-8343
Homepage URL
Email yahataendo@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Fiber Medicine Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee of Tohoku University Graduate School of Dentistry
Address 4-1, Seiryo-machi, Aoba, Sendai 980-8575, Miyagi
Tel 022-717-8244
Email den-syom@grp.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
2021 Year 07 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 07 Day
Last follow-up date
2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of disease activity of Crohn's disease by saliva test
The saliva test value and the CDAI score will be tracked longitudinally to evaluate the correlation of each. By using blood tests together, salivary biomarkers reflecting inflammation status will be identified. In addition, the specificity of saliva test for reflecting the disease activity of Crohn's disease is also evaluated by setting control group having no systemic disease.

Management information
Registered date
2020 Year 05 Month 08 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046033

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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