UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042754 |
|---|---|
| Receipt number | R000048798 |
| Scientific Title | A cross-sectional study to determine whether periodontal disease and periodontal bacteria are associated with the development of NASH-derived liver cancer |
| Date of disclosure of the study information | 2020/12/14 |
| Last modified on | 2020/12/14 21:54:46 |
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Basic information
Public title
Study of the relationship among the development of NASH-derived liver cancer, periodontal disease and periodontal bacteria
Acronym
Periodontal disease - liver cancer study
Scientific Title
A cross-sectional study to determine whether periodontal disease and periodontal bacteria are associated with the development of NASH-derived liver cancer
Scientific Title:Acronym
Periodontal disease - a cross-sectional study of liver cancer
Region
| Japan |
Condition
Condition
Non-alcoholic steatohepatitis:NASH, Liver cancer from NASH, Periodontal disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify whether periodontal disease and periodontal bacteria are related to the development of NASH-derived liver cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathogenesis of NASH and NASH-derived liver cancer, pathogenesis of periodontal disease, oral microflora, and intestinal microflora
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with NASH and NASH-derived liver cancer who visited the Department of Gastroenterology, Yokohama City University Hospital
Key exclusion criteria
Patients who have taken antibiotics within one month from the date of internal medicine and periodontal examination.
Toothless patient
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Minabe |
Organization
Graduate School of Dentistry Kanagawa Dental University
Division name
Division of Periodontology Department of Oral Interdisciplinary Medicine
Zip code
238-8580
Address
82 Inaoka, Yokosuka 2388580, Kanagawa, Japan
TEL
046-822-9581
minabe@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Morozumi |
Organization
Graduate School of Dentistry Kanagawa Dental University
Division name
Division of Periodontology Department of Oral Interdisciplinary Medicine
Zip code
238-8580
Address
82 Inaoka, Yokosuka 2388580, Kanagawa, Japan
TEL
046-822-8855
Homepage URL
morozumi@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University Research Ethics Review Committee
Address
82 Inaoka, Yokosuka 2388580, Kanagawa, Japan
Tel
046-822-8813
kenkyo@kdu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
624
Org. issuing International ID_1
Kanagawa Dental Uiversity Research Ethics Review Committee
Study ID_2
B20010001
Org. issuing International ID_2
Public University Corporation Yokohama City University Medical Ethics Committee for Human Subjects
IND to MHLW
Institutions
Institutions
横浜市立大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 14 | 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
| 2019 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe the relationship between the pathogenesis of periodontal disease, periodontal bacteria, and intestinal bacteria with the development of NASH-derived liver cancer.
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048798
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|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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