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

Renal Cell Carcinoma Clinical Trial

Official title:

Treatment Patterns and Outcomes in Unresectable or Metastatic Renal Cell Carcinoma (mRCC) Patients in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161145
• Other study ID #: CA209-770
• Status: Completed
• Phase: N/A
• First received: May 17, 2017
• Last updated: October 2, 2017
• Start date: December 9, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Japan	Local Institution	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form