Renal Cell CarcinomaNCT03161145
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
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 297 participants
- Where
- 1 siteJapan
- Study dates
- 9 Dec 2016to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Previously and/or currently enrolled in RCC clinical trials
- Patients have primary cancer other than renal cell cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Patterns and Outcomes in Unresectable or Metastatic Renal Cell Carcinoma (mRCC) Patients in Japan
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
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unresectable or metastatic renal cell carcinoma (mRCC) | Medical records will be reviewed for treatment patterns and outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment patterns
measured by retrospective data collection of treatment regimen and duration (including rate of permanent and temporary discontinuation)
Measured: Approximately 5 years
Overall survival
measured by data collection in years
Measured: Approximately 2 years
Reason for terminating or switching treatment
measured by data collection information available in retrospective analysis, if disclosed
Measured: Approximately 5 years
Adverse Events
measured by data collection
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start9 Dec 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161145
- Sponsor's protocol ID
- CA209-770
- Status last verified
- Oct 2017
- First submitted
- 17 May 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes in Unresectable or Metastatic Renal Cell Carcinoma (mRCC) Patients in Japan
- ClinicalTrials.gov ID
- NCT03161145
- Acronym / sponsor ID
- CA209-770
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unresectable or metastatic renal cell carcinoma (mRCC) | – | –Medical records will be reviewed for treatment patterns and outcomes |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Previously and/or currently enrolled in RCC clinical trials
- Patients have primary cancer other than renal cell cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment patterns
Time frame: Approximately 5 years
measured by retrospective data collection of treatment regimen and duration (including rate of permanent and temporary discontinuation)
Overall survival
Time frame: Approximately 2 years
measured by data collection in years
Reason for terminating or switching treatment
Time frame: Approximately 5 years
measured by data collection information available in retrospective analysis, if disclosed
Adverse Events
Time frame: Approximately 5 years
measured by data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment patterns (time frame: Approximately 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.