UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046059 |
|---|---|
| Receipt number | R000052543 |
| Scientific Title | Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2021/11/12 17:43:50 |
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Basic information
Public title
Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Acronym
Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Scientific Title
Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Scientific Title:Acronym
Exploratory study for salivary biomarkers that reflect disease activity over time in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a bioresource to search biomarkers that reflect disease activity from saliva of patients with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
In this study, saliva samples from patients with inflammatory bowel disease will be collected in order to establish a bioresource for the discovery of biomarkers that reflect the disease activity of inflammatory bowel disease patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will search biomarkers in saliva that reflect the disease activity of inflammatory bowel disease and analyze the results of periodontal examinations to evaluate the relationship between salivary biomarkers and the disease activity of inflammatory bowel 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing endoscopy at the Department of Gastroenterology, Tohoku University Hospital for the diagnosis of inflammatory bowel diseases including ulcerative colitis or Crohn's disease.
Key exclusion criteria
Patients who have a stoma, or have a medical or mental abnormality that makes it difficult to comply with protocol, or doctor decides inappropriate.
Target sample size
40
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
Department of Operative Dentistry
Zip code
989-8575
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL
022-717-8340
masahiro.saito.c5@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
Department of Operative Dentistry
Zip code
989-8575
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL
022-717-8340
Homepage URL
masahiro.saito.c5@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University ethics committee
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
Tel
022-728-4105
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
| 2024 | Year | 04 | 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
| 2021 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, saliva will be collected as an observational study, along with periodontal histology, radiography, and intraoral photographs of the subjects.
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052543
