UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052956 |
|---|---|
| Receipt number | R000060422 |
| Scientific Title | Prospective observational study on the association between imaging, histopathology, bacteriology, surgical technique and course of treatment in cases of Medication-related Osteonecrosis of the jaw. |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2023/11/30 15:59:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective observational study on the association between imaging, histopathology, bacteriology, surgical technique and course of treatment in cases of Medication-related Osteonecrosis of the jaw.
Acronym
Prospective observational study on the association between imaging, histopathology, bacteriology, surgical technique and course of treatment in cases of Medication-related Osteonecrosis of the jaw.
Scientific Title
Prospective observational study on the association between imaging, histopathology, bacteriology, surgical technique and course of treatment in cases of Medication-related Osteonecrosis of the jaw.
Scientific Title:Acronym
Prospective observational study on the association between imaging, histopathology, bacteriology, surgical technique and course of treatment in cases of Medication-related Osteonecrosis of the jaw.
Region
| Japan |
Condition
Condition
medication-related osteonecrosis of the jaw
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between preoperative imaging findings and postoperative histopathological and bacteriological findings in order to consider the appropriate extent of resection of MRONJ.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Imaging findings (CT, MR, SPECT-CT)
Histopathological findings
Bacteriological findings by Real-time PCR
Outcome
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients aged 18 years and over undergoing surgery under general anaesthesia at MRONJ
(ii) Patients who visited our oral surgery department between the date of approval by the director of the research institute and 31 March 2025
(iii) Patients for whom IC was obtained from the patient or a surrogate.
Key exclusion criteria
(i) Patients with a small extent of resection (e.g. removal of putrefied bone)
(ii) Other patients deemed inappropriate as research subjects by researchers and others.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Mitsunobu |
Organization
Nagasaki University Hospital
Division name
Oral and Maxillofacial surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7698
m-ohnuma@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Mitsunobu |
Organization
Nagasaki University Hospital
Division name
Oral and Maxillofacial surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7698
Homepage URL
m-ohnuma@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7200
gaibushikin@ml.nagasaki-u.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
| 2024 | Year | 01 | Month | 20 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
