A Study to Observe the Treatment Patterns and Outcomes of... | NCT03161145

Studies
A Study to Observe the Treatment Patterns and Outcomes of Patients in Japan With Kidney Cancer That is Unable to be Removed by Surgery or That Has Spread

NCT03161145

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 3, 2017Actual

Enrollment

297Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2016Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

May 18, 2017

First Posted Date

May 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A medical review chart study in Japan to describe the treatment patterns and outcomes of patients with kidney cancer that is unable to be removed by surgery or that has spread. The clinical data is to be abstracted using electronic data capture (eDC) from patient medical records in Japan.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

297Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unresectable or metastatic renal cell carcinoma (mRCC)		Medical records will be reviewed for treatment patterns and outcomes

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment patterns	measured by retrospective data collection of treatment regimen and duration (including rate of permanent and temporary discontinuation)	Approximately 5 years
Overall survival	measured by data collection in years	Approximately 2 years
Reason for terminating or switching treatment	measured by data collection information available in retrospective analysis, if disclosed	Approximately 5 years
Adverse Events	measured by data collection	Approximately 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Adults 20 years and older at the time of initial diagnosis of mRCC
Alive or deceased as of the date of data collection
Diagnosis of mRCC between 01-Jan-2012 and 31-Aug-2015

Exclusion Criteria:

Previously and/or currently enrolled in RCC clinical trials
Patients have primary cancer other than renal cell cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The medical records of about 500 patients diagnosed with unresectable or metastatic renal cell carcinoma, including those who have progressed from or discontinued from first-line therapy, between 01-Jan-2012 and 31-Aug-2015 will be enrolled in this study from sites in Japan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Tokyo		1070052	Japan

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided