UMIN-CTR Clinical Trial

Basic information
Public title	Detecting the precise degree for bone invasion of oral cancer. : Comparison of pathological specimen and diagnostic imaging methods.
Acronym	Comparison of pathological specimen and diagnostic imaging methods for detecting the precise degree for bone invasion of oral cancer.
Scientific Title	Detecting the precise degree for bone invasion of oral cancer. : Comparison of pathological specimen and diagnostic imaging methods.
Scientific Title:Acronym	Comparison of pathological specimen and diagnostic imaging methods for detecting the precise degree for bone invasion of oral cancer.
Region	Japan

Condition
Condition	oral cancer
Classification by specialty	Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, we carry out the comparison of pathological features of oral squamous cell carcinoma (OSCC) with bone invasion between preoperative and evaluated capacity of accurate imaging bone invasion with some device and outcomes of surgical removal of bone with or without tumor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All patients had 5 preoperative image diagnosis methods, contrast enhanced MRI, CT, 99mTc scintigraphy (TC scan), FDG-PET CT (PET/CT) and panoramic radiograph (PR). Among bone invasion, sensitivity and specificity were calculated for these images, comparing pathological finding.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	All patients had 5 preoperative image diagnosis methods, contrast enhanced MRI, CT, 99mTc scintigraphy (TC scan), FDG-PET CT (PET/CT) and panoramic radiograph (PR). Among bone invasion, sensitivity and specificity were calculated for these images, comparing pathological finding.
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	30 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The study participants were 30 patients who were scheduled for mandibulectomy or maxillectomy with OSCC.
Key exclusion criteria	The not suitable study participants were patients who were disagree this study or lucked imaging or a minor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsumu Middle name Last name Kouketsu
Organization	Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Division name	Division of Oral and Maxillofacial Surgery
Zip code	980-8575
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	022-717-8350
Email	kouketsu_atsumu@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Atsumu Middle name Last name Kouketsu
Organization	Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Division name	Division of Oral and Maxillofacial Surgery
Zip code	980-8575
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	022-717-8350
Homepage URL
Email	kouketsu_atsumu@dent.tohoku.ac.jp

Sponsor
Institute	Division of Oral and Maxillofacial Surgery, Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Division of Oral and Maxillofacial Surgery, Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Oral and Maxillofacial Surgery, Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tel	022-717-8350
Email	kouketsu_atsumu@dent.tohoku.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

Other administrative information
Date of disclosure of the study information	2017 Year 05 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	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry	2021 Year 04 Month 20 Day
Date trial data considered complete	2021 Year 04 Month 20 Day
Date analysis concluded	2021 Year 04 Month 20 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 17 Day
Last modified on	2021 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030981