UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Molecular pathological study on fibroplastic lesions of the oral primary origin.
Title of the study (Brief title)	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	Keiichi Tsukiki
Organization	Kanagawa Dental College Graduate School
Division name	Environmental Pathology Course
Address	Kanagawa prefecture Yokosuka-shi Inaoka cho 82
TEL	046-822-8866
Email	tsukinoki@kdu.ac.jp

Public contact
Name of contact person	Masako Nagasaki
Organization	Kanagawa Dental College Graduate School
Division name	Environmental Pathology Course
Address	Kanagawa prefecture Yokosuka-shi Inaoka cho 82
TEL	046-822-8866
Homepage URL
Email	ma80422@yahoo.co.jp

Sponsor
Institute	Kanagawa Dental College
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036216