UMIN-CTR Clinical Trial

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