UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004730
Receipt number R000005631
Scientific Title Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor
Date of disclosure of the study information 2010/12/15
Last modified on 2013/01/29 11:47:30

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Basic information

Public title

Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor

Acronym

Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor

Scientific Title

Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor

Scientific Title:Acronym

Retrospective observational study in patients with renal cell carcinoma treated by everolimus, mTOR inhibitor

Region

Japan


Condition

Condition

Advanced renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the study is, by collecting safety and efficacy data of everolimus in patients with renal cell carcinoma as quickly as possible, to generate preliminary information on safety and efficacy of the product.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Safety

Key secondary outcomes

1) ORR
2) PFS


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Unresectable or metastatic patients with renal cell carcinoma treated by everolimus
2) Patients who did not refuse against the provision of treatment data

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotsugu Uemura

Organization

Kinki University School of Medicine

Division name

Department of Urology

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan

TEL

072-366-0221

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Yoshimura

Organization

Kinki University School of Medicine

Division name

Department of Urology

Zip code


Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Department of Urology, Kinki University School of Medicine

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


Address


Tel


Email



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

近畿大学(大阪府)、大阪医科大学(大阪府)、関西医科大学(大阪府)、大阪市立大学(大阪府)、大阪大学(大阪府)、京都府立医科大学(京都府)、神戸大学(兵庫県)、和歌山県立医科大学(和歌山県)、北海道大学(北海道)、山形大学(山形県)、伊勢崎市民病院(群馬県)、千葉県がんセンター(千葉県)、日本大学(東京都)、名古屋市立大学(愛知県)、藤田保健衛生大学(愛知県)、三重大学(三重県)、金沢大学(石川県)、広島大学(広島県)、徳島大学(徳島県)、愛媛大学(愛媛県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 15 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

2010 Year 08 Month 06 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 03 Month 01 Day

Date of closure to data entry

2012 Year 06 Month 01 Day

Date trial data considered complete

2012 Year 09 Month 01 Day

Date analysis concluded

2012 Year 12 Month 01 Day


Other

Other related information

The purpose of the study is, by collecting safety and efficacy data of everolimus in patients with renal cell carcinoma as quickly as possible, to generate preliminary information on safety and efficacy of the product. To minimize site-related biases, the investigators should collect data of all patients who have initiated everolimus treatment.


Management information

Registered date

2010 Year 12 Month 15 Day

Last modified on

2013 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name