UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of Puncture Resistance in Surgical Specimens of Renal Cell Carcinoma
Acronym	Measurement of Puncture Resistance in Surgical Specimens of Renal Cell Carcinoma
Scientific Title	Measurement of Puncture Resistance in Surgical Specimens of Renal Cell Carcinoma
Scientific Title:Acronym	Measurement of Puncture Resistance in Surgical Specimens of Renal Cell Carcinoma
Region	Japan

Condition
Condition	Renal cell carcinoma
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A new needle puncture system which can reduce puncture resistance is being studied. As a part of this, we measure puncture force of the system using tumors excised at surgery.
Basic objectives2	Others
Basic objectives -Others	Puncture force measurement in surgical specimens.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Puncture force measurement in surgical specimens.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Scheduled surgery for renal cell carcinoma (nephrectomy, partial nephrectomy). (2) Tumor size less than 4cm and equivalent to T1a in TNM classification.
Key exclusion criteria	Cystic renal cell carcinoma
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Tomomi Middle name Last name Sato
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Zip code	980-8574
Address	1-1 Seiryo, Aoba, Sendai
TEL	022-717-7312
Email	tomomi.sato.e2@tohoku.ac.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Sato
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Zip code	980-8574
Address	1-1 Seiryo, Aoba, Sendai
TEL	022-717-7312
Homepage URL
Email	tomomi.sato.e2@tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
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	Ethics Committee Tohoku University Hospital
Address	1-1 Seiryo, Aoba, Sendai
Tel	022-728-4105
Email	ec@rinri.hosp.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	2021 Year 12 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	Enrolling by invitation
Date of protocol fixation	2021 Year 03 Month 30 Day
Date of IRB	2021 Year 03 Month 30 Day
Anticipated trial start date	2021 Year 03 Month 30 Day
Last follow-up date	2022 Year 08 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	2021 Year 11 Month 30 Day
Last modified on	2021 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052769