UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041358
Receipt number 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 2022/06/14 09:46:43

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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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

Completed

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

2022 Year 06 Month 14 Day



Link to view the page

Value
https://center6.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