Study Stopped
Business objectives have changed
Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents
A Healthcare Cost and Resource Utilization Analysis of Intravenous and Oral Agents in the Treatment of Metastatic Renal Cell Carcinoma
1 other identifier
observational
N/A
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedJuly 17, 2017
July 1, 2017
3 months
October 7, 2016
July 13, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
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
Up to 63 months
Medication Possession Ratio (MPR) for patients treated with IV drugs used in the first-line treatment of mRCC
Up to 63 months
Study Arms (2)
Patients treated with IV agents
Metastatic renal cell carcinoma patients treated with IV agents
Patients treated with oral agents
Metastatic renal cell carcinoma patients treated with oral agents
Interventions
Eligibility Criteria
Metastatic RCC patients in the US identified from administrative claim databases
You may qualify if:
- Diagnosis with metastatic renal cell carcinoma
- Prescription/administration of one of the IV or oral agents examined in the study
You may not qualify if:
- Patients with other primary cancer diagnosis before RCC diagnosis
- Patients with pregnancy or HIV/AIDS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bristol-Myers Squibb
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
February 28, 2017
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
July 17, 2017
Record last verified: 2017-07