UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040340 |
|---|---|
| Receipt number | 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 19:30:27 |
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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
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
yahataendo@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046033
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
