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 | Completed

• 1 other identifier: CA209-770
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Unresectable or metastatic renal cell carcinoma (mRCC)

Medical records will be reviewed for treatment patterns and outcomes

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Local Institution

Tokyo, 1070052, Japan

Location

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: December 9, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-10

Locations

JP (1)