UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027019 |
|---|---|
| Receipt number | R000030981 |
| Scientific Title | Detecting the precise degree for bone invasion of oral cancer. : Comparison of pathological specimen and diagnostic imaging methods. |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2021/04/20 09:51:10 |
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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
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
kouketsu_atsumu@dent.tohoku.ac.jp
Sponsor or person
Institute
Division of Oral and Maxillofacial Surgery, Department of Oral Medicine and Surgery, Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030981
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