UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058799 |
|---|---|
| Receipt number | R000067178 |
| Scientific Title | Genetic Analysis of Sclerosing Odontogenic Carcinoma Using Next-Generation Sequencing |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/13 18:56:25 |
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Basic information
Public title
Sclerosing Odontogenic Carcinoma Genetic Analysis Test
Acronym
Sclerosing Odontogenic Carcinoma Test
Scientific Title
Genetic Analysis of Sclerosing Odontogenic Carcinoma Using Next-Generation Sequencing
Scientific Title:Acronym
Sclerosing Odontogenic Carcinoma Test
Region
| Japan |
Condition
Condition
Sclerosing Odontogenic Carcinoma
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Our aim is to establish the criteria of sclerosing odontogenic carcinoma by genetic analysis.
Basic objectives2
Others
Basic objectives -Others
Exploration of Pathogenesis Through Genetic Analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic analysis of sclerosing odontogenic carcinoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Genetic analysis of archived surgical specimen
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient of sclerosing odontogenic carcinoma
Key exclusion criteria
Under 20 years old
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kurita |
Organization
Shinshu University School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan
TEL
0263354600
24hb406a@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Tonouchi |
Organization
Shinshu University School of Medicine
Division name
Department of Oral and Maxillofacial Surgery
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan
TEL
0263354600
Homepage URL
24hb406a@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto-shi, Nagano, Japan
Tel
0263354600
mdaigak@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
6386
Org. issuing International ID_1
Shinshu University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 30 | 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
3
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067178
