UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000029861
Receipt number R000034106
Scientific Title Association between CTC and tumor shrinkage by TKI treatment on RCC patients
Date of disclosure of the study information 2018/11/07
Last modified on 2020/05/15 17:30:00

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Basic information

Public title

Association between CTC and tumor shrinkage by TKI treatment on RCC patients

Acronym

Association between CTC and tumor shrinkage by TKI treatment on RCC patients

Scientific Title

Association between CTC and tumor shrinkage by TKI treatment on RCC patients

Scientific Title:Acronym

Association between CTC and tumor shrinkage by TKI treatment on RCC patients

Region

Japan


Condition

Condition

renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To analyze the correlation between CTC and tumor shrinkage by TKI treatment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

number of CTC
tumor shrinkage,

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sunitinib treatment

Interventions/Control_2

Pazopanib treatment

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with metastatic clear cell renal cell carcinoma, PS; 0-1
Patients who do not have bone marrow suppression nor liver and/or renal disfunction. Patients who would have 1st line treatment.

Key exclusion criteria

Who have other malignancy
Who have allergy to TKI
or pregnant

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yoshiyuki
Middle name
Last name Kojima

Organization

Fukushima Medical University

Division name

Department of Urology

Zip code

960-1295

Address

1 Hikarigaoka , Fukushima

TEL

024-547-1316

Email

urol@fmu.ac.jp


Public contact

Name of contact person

1st name Tomoyuki
Middle name
Last name Koguchi

Organization

Fukushima Medical University

Division name

Department of Urology

Zip code

960-1295

Address

1 Hikarigaoka , Fukushima

TEL

024-547-1316

Homepage URL


Email

gucchii@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

We have no conflict of Interest.

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

Fukushima Medical University

Address

1 Hikarigaoka Fukushima City

Tel

024-547-1771

Email

rs@fmu.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

2018 Year 11 Month 07 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

2017 Year 10 Month 31 Day

Date of IRB

2017 Year 06 Month 01 Day

Anticipated trial start date

2017 Year 11 Month 07 Day

Last follow-up date

2022 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 07 Day

Last modified on

2020 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name