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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041358
Receipt No. R000046927
Scientific Title Prospective evaluation of core number of small renal tumor biopsies: single vs multiple (SCIRO-2003)
Date of disclosure of the study information 2020/10/01
Last modified on 2021/01/20

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Basic information
Public title Prospective evaluation of core number of small renal tumor biopsies: single vs multiple (SCIRO-2003)
Acronym Prospective evaluation of multiple core fires of small renal tumor biopsies: (SCIRO-2003)
Scientific Title Prospective evaluation of core number of small renal tumor biopsies: single vs multiple (SCIRO-2003)
Scientific Title:Acronym Prospective evaluation of multiple core fires of small renal tumor biopsies: (SCIRO-2003)
Region
Japan

Condition
Condition Renal tumor
Classification by specialty
Urology Radiology Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prospectively evaluate the efficacy of multiple biopsies for renal tumors, comparing with single biopsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic accuracies of "first sample alone" and "all samples"
Key secondary outcomes Feasibility of achieving multiple samples
Suitability of samples
Histological diagnosis
RCC subtype
RCC Fuhrman grade

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Following separating first and other specimens, diagnosis of renal tumor is made on the first specimen alone and all specimens, respectively.
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) Renal tumor exists and is an indication for an image-guided biopsy.
2) Diameter of renal tumor > 1.5cm.
3) Age >= 20.
4) Patients who can understand the concept of the study and consented to participate in the study.
Key exclusion criteria 1) Tumor is cystic.
2) Tumor has an obvious fat component.
3) Patient has abnormal laboratory data including WBC, Hb, PLT, and PT.
4) Pregnant.
5) Patient has a mental illness, including dementia.
6) Patients cannot stay still.
7) Not eligible determined by the responding physician.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Toshihiro
Middle name
Last name Iguchi
Organization Okayama University Hospital
Division name Department of Radiology
Zip code 7008558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL +81-86-235-7315
Email iguchi@okayama-u.ac.jp

Public contact
Name of contact person
1st name Toshihiro
Middle name
Last name Iguchi
Organization Okayama University Hospital
Division name Department of Radiology
Zip code 7008558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL +81-86-235-7315
Homepage URL
Email iguchi@okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel +81-86-235-6503
Email mae6605@adm.okayama-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
2020 Year 10 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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 13 Day
Date of IRB
2020 Year 10 Month 06 Day
Anticipated trial start date
2020 Year 10 Month 07 Day
Last follow-up date
2022 Year 12 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
2020 Year 08 Month 08 Day
Last modified on
2021 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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