UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043900 |
|---|---|
| Receipt number | R000050131 |
| Scientific Title | Boring biopsy: A preliminary study of a novel approach to brain biopsy |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2021/04/12 17:00:44 |
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Basic information
Public title
Boring biopsy: A preliminary study of a novel approach to brain biopsy
Acronym
Boring biopsy: A preliminary study of a novel approach to brain biopsy
Scientific Title
Boring biopsy: A preliminary study of a novel approach to brain biopsy
Scientific Title:Acronym
Boring biopsy: A preliminary study of a novel approach to brain biopsy
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are several methods to biopsy intraparenchymal brain lesions, including stereotactic biopsy and open block biopsy, both of which have advantages and disadvantages. We propose a novel biopsy method for intraparenchymal brain lesions, called boring biopsy which aims to overcome the drawbacks of each conventional method. The boring biopsy is minimally invasive and allows continuous specimens of sufficient volume to be obtained. This study aimed to assess the feasibility and efficacy of using boring biopsy for intraparenchymal brain lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patient- and tumor-related characteristics of interest were sex, age, tumor location, the accuracy of target sampling, histopathology findings, and complications. The accurate biopsy point was defined as the correspondence between the preoperative target point and resected point, based on postoperative magnetic resonance imaging (MRI) or computed tomography (CT) scans.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with biopsy for intraparenchymal lesion with boring biopsy method from 7 April 2021 to 31 March 2024
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) All patients aged 16 years or older who have brain lesions requiring pathological diagnosis and who are judged to be suitable for bowling biopsy (2) Patients for whom written consent was obtained based on the free will of the patient or his / her substitute after receiving sufficient explanation for participation in this study.
Key exclusion criteria
(1) Patients judged by the principal investigator to be inappropriate as subjects (2)Patients with hypersensitivity or allergy to nickel titanium alloy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Ogiwara |
Organization
Shinshu University School of Medicine
Division name
Neurosurgery
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto
TEL
0263372690
togiwara@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Ogiwara |
Organization
Shinshu University School of Medicine
Division name
Neurosurgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto
TEL
0263372690
Homepage URL
togiwara@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto
Tel
0263372572
mdrinri@shinshu-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
| 2021 | Year | 04 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050131
