UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031707 |
|---|---|
| Receipt number | R000036216 |
| Scientific Title | Molecular pathological study on fibroplastic lesions of the oral primary origin. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2018/03/26 16:17:05 |
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Basic information
Public title
Molecular pathological study on fibroplastic lesions of the oral primary origin.
Acronym
Molecular pathological study on fibroplastic lesions of the oral primary origin.
Scientific Title
Molecular pathological study on fibroplastic lesions of the oral primary origin.
Scientific Title:Acronym
Molecular pathological study on fibroplastic lesions of the oral primary origin.
Region
| Japan |
Condition
Condition
Denture fibroma,Epuris,Lrritative fibroma,True fibroma
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It becomes possible to distinguish several lesions potentially contained in irritating fibroma and it is possible to distinguish between real tumor reactive diseases at the molecular pathological level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differentiation of lesions potentially contained in irritating fibroma
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients clinically diagnosed with denture fibroma, fibrous epulis, true fibroma, irritant fibroma at Kanagawa Dental University attached hospital
Key exclusion criteria
nothing special
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Tsukiki |
Organization
Kanagawa Dental College Graduate School
Division name
Environmental Pathology Course
Zip code
Address
Kanagawa prefecture Yokosuka-shi Inaoka cho 82
TEL
046-822-8866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Nagasaki |
Organization
Kanagawa Dental College Graduate School
Division name
Environmental Pathology Course
Zip code
Address
Kanagawa prefecture Yokosuka-shi Inaoka cho 82
TEL
046-822-8866
Homepage URL
ma80422@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Dental College
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University Graduate School Course
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
Address
Tel
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 | 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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Samples collected will be divided into 2 pathological diagnostic specimens and study specimens. The purpose of this research is to conduct a detailed search of genes and proteins.
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036216
