UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049170 |
|---|---|
| Receipt number | R000055982 |
| Scientific Title | Assessments of intraoperative flow cytometer |
| Date of disclosure of the study information | 2022/10/10 |
| Last modified on | 2024/04/11 13:03:38 |
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Basic information
Public title
Assessments of the new cutoff value and the accuracy of Intraoperative flow cytometer for the intraoperative frozen section diagnosis and the intraoperative frozen section diagnosis of the resection margin in malignant brain tumor surgery
Acronym
Assessments of intraoperative flow cytometer
Scientific Title
Assessments of intraoperative flow cytometer
Scientific Title:Acronym
IFC-A
Region
| Japan |
Condition
Condition
Malignant Brain Tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the accuracy of the intraoperative flow cytometer in surgical explanted specimens, we will compare the accuracy of the intraoperative frozen diagnosis by pathology with that of the intraoperative frozen section of tumor marginal specimens.
Basic objectives2
Others
Basic objectives -Others
Accuracy verification
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
calculation of malignant index level
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoperative flow cytometer
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) All patients with gliomas (benign and malignant), metastatic brain tumors, and other malignant brain tumors who undergo surgery in our department.
2) Patients of any age and gender.
3) Written consent to participate in the study must be obtained from the patient or a substitute author.
Key exclusion criteria
1) Patients with a preoperative diagnosis of a non-glioma benign brain tumor.
2) For tumors of obvious intraventricular origin with minimal intracerebral attachment.
3) For tumors within the brain trunk.
4) In the case of tumors in the mesencephalic/pituitary region.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichiroh |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University Graduate School of Medicine
Division name
Neurosurgery
Zip code
036-8562
Address
Zaifu-cho 5, Hirosaki-shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
asanoken@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiroh |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University Graduate School of Medicine
Division name
Neurosurgery
Zip code
036-8562
Address
Zaifu-cho 5, Hirosaki-shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
Homepage URL
https://hirosaki-u-neuros.jp
asanoken@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Kohden
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
Zaifu-cho 5, Hirosaki-shi, Aomori Prefecture, 036-8562, Japan
Tel
0172-33-5111
rinri@hirosaki-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
| 2022 | Year | 10 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055982
