UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057717 |
|---|---|
| Receipt number | R000065947 |
| Scientific Title | Investigation of the relationship between ameloblastoma and salivary uric acid levels and microRNAs |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/25 14:47:06 |
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Basic information
Public title
Investigation of the relationship between ameloblastoma and salivary uric acid levels and microRNAs
Acronym
Uric acid levels and miRNAs in patients with ameloblastoma
Scientific Title
Investigation of the relationship between ameloblastoma and salivary uric acid levels and microRNAs
Scientific Title:Acronym
Uric acid levels and miRNAs in patients with ameloblastoma
Region
| Japan |
Condition
Condition
ameloblastoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Extract new clinical markers for ameloblastoma by identifying the relationship between ameloblastoma and uric acid levels and miRNAs associated with with cell proliferation.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary uric acid levels
Key secondary outcomes
,miRNAs associated with cell proliferation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Other |
Interventions/Control_1
Measuring salivary uric acid levels and miRNAs involved in cell proliferation in patients with ameloblastoma.
Interventions/Control_2
Measuring salivary uric acid levels and miRNAs involved in cell proliferation in healthy subjects.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient group
(1) Patients who have been diagnosed with enamel epithelioma (postoperative and scheduled surgery patients) in Department of Oral and Maxillofacial Surgery, Fukuoka Dental College Hospital.
(2) Patients who fully understand this research plan and can give informed consent by themselves or their family (parents and guardians of minors).
(3) Age 16 years or older at the time of obtaining informed consent.
Control group
(1) Patients who visit the outpatient dental clinic of Fukuoka Dental College Hospital with the main complaint of seeking dental treatment and are diagnosed as having no history of systemic diseases including ameloblastoma.
(2) Patients who fully understand this research plan and can give informed consent by themselves or their family members.
Key exclusion criteria
Patient group
(1) Patients who could not obtain consent.
(2) Patients who are under treatment for or have a history of malignancy including oral cancer.
(3) Other patients whom the investigator judges to be inappropriate as research subjects.
(4) When consent is withdrawn during the study.
Control group
(1) Patients who could not obtain consent.
(2) Patients who are under treatment for or have a history of malignancy including oral cancer.
(3) Other patients whom the investigator judged to be inappropriate as research subjects.
(4) In case of withdrawal of consent during the course of the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Morita |
Organization
Fukuoka Dental College
Division name
Section of Dentistry for the Disabled, Department of Oral Growth and Development
Zip code
814-0193
Address
Tamura 2-15-1, Sawara-ku, Fukuoka
TEL
092-801-0425
morita@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Morita |
Organization
Fukuoka Dental College
Division name
Section of Dentistry for the Disabled, Department of Oral Growth and Development
Zip code
814-0193
Address
Tamura 2-15-1, Sawara-ku, Fukuoka
TEL
092-801-0425
Homepage URL
morita@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Hiromitsu Morita
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Dental College
Address
Tamura 2-15-1, Sawara-ku, Fukuoka
Tel
092-801-0425
shomu@fdcnet.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
福岡歯科大学医科歯科総合病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065947
