UMIN-CTR Clinical Trial

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
Email	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
Email	togiwara@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050131