Renal Cell CarcinomaNCT02928263
Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents
An observational study of Renal Cell Carcinoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Non-Interventional
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 31 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Metastatic RCC patients in the US identified from administrative claim databases
Who may be able to join
- Diagnosis with metastatic renal cell carcinoma
- Prescription/administration of one of the IV or oral agents examined in the study
Who cannot join
- Patients with other primary cancer diagnosis before RCC diagnosis
- Patients with pregnancy or HIV/AIDS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Healthcare Cost and Resource Utilization Analysis of Intravenous and Oral Agents in the Treatment of Metastatic Renal Cell Carcinoma
A retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents
- Conditions
- Renal Cell Carcinoma
- Being tested
- Non-Interventional
- 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.
Non-InterventionalOther
Other
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with IV agents | Metastatic renal cell carcinoma patients treated with IV agents Receives: Other: Non-Interventional | |
| Patients treated with oral agents | Metastatic renal cell carcinoma patients treated with oral agents Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Healthcare costs for patients treated with oral drugs used in the first-line treatment of Metastatic renal cell carcinoma (mRCC)
All-cause healthcare costs will be calculated in the first-line oral cohort as per-patient-per-month (PPPM) costs.
Measured: Up to 63 months
Composite of Resource Utilization for patients treated with oral drugs used in the first-line treatment of mRCC
Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.
Measured: Up to 63 months
Distribution of Healthcare costs for patients treated with IV drugs used in the first-line treatment of mRCC
All-cause healthcare costs will be calculated in the first-line IV cohort as per-patient-per-month (PPPM) costs.
Measured: Up to 63 months
Composite of Resource Utilization for patients treated with IV drugs used in the first-line treatment of mRCC
Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.
Measured: Up to 63 months
Secondary outcomes (2)
Medication Possession Ratio (MPR) for patients treated with oral drugs used in the first-line treatment of mRCC
MPR will be calculated for each index drug as the ratio of the sum of the total number of days' supply to the total number of days in the follow-up period.
Measured: Up to 63 months
Medication Possession Ratio (MPR) for patients treated with IV drugs used in the first-line treatment of mRCC
MPR will be calculated for each index drug as the ratio of the sum of the total number of days' supply to the total number of days in the follow-up period.
Measured: Up to 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start28 Feb 2017
- Primary completion31 May 2017 (estimated)
- Study completion31 May 2017 (estimated)
Why it stopped: Business objectives have changed
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928263
- Sponsor's protocol ID
- CA209-780
- Status last verified
- Jul 2017
- First submitted
- 7 Oct 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Healthcare Cost and Resource Utilization Analysis of Intravenous and Oral Agents in the Treatment of Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02928263
- Acronym / sponsor ID
- CA209-780
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 31 May 2017 (estimated)
- Study completion
- 31 May 2017 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- 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 retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with IV agents | – | Other: Non-InterventionalMetastatic renal cell carcinoma patients treated with IV agents |
| Patients treated with oral agents | – | Other: Non-InterventionalMetastatic renal cell carcinoma patients treated with oral agents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Metastatic RCC patients in the US identified from administrative claim databases
Key inclusion criteria (2 listed)
- Diagnosis with metastatic renal cell carcinoma
- Prescription/administration of one of the IV or oral agents examined in the study
Key exclusion criteria (2 listed)
- Patients with other primary cancer diagnosis before RCC diagnosis
- Patients with pregnancy or HIV/AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalOther | Other | Patients treated with IV agents, Patients treated with oral agents |
Primary outcome
Distribution of Healthcare costs for patients treated with oral drugs used in the first-line treatment of Metastatic renal cell carcinoma (mRCC)
Time frame: Up to 63 months
All-cause healthcare costs will be calculated in the first-line oral cohort as per-patient-per-month (PPPM) costs.
Composite of Resource Utilization for patients treated with oral drugs used in the first-line treatment of mRCC
Time frame: Up to 63 months
Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.
Distribution of Healthcare costs for patients treated with IV drugs used in the first-line treatment of mRCC
Time frame: Up to 63 months
All-cause healthcare costs will be calculated in the first-line IV cohort as per-patient-per-month (PPPM) costs.
Composite of Resource Utilization for patients treated with IV drugs used in the first-line treatment of mRCC
Time frame: Up to 63 months
Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.
2 secondary outcomes
Medication Possession Ratio (MPR) for patients treated with oral drugs used in the first-line treatment of mRCC
Time frame: Up to 63 months
Medication Possession Ratio (MPR) for patients treated with IV drugs used in the first-line treatment of mRCC
Time frame: Up to 63 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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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 United States.
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 2 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: withdrawn, as of the sponsor's last update on 17 Jul 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Distribution of Healthcare costs for patients treated with oral drugs used in the first-line treatment of Metastatic renal cell carcinoma (mRCC) (time frame: Up to 63 months). 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 17 Jul 2017.