Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents

July 13, 2017 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Bristol-Myers Squibb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Metastatic RCC patients in the US identified from administrative claim databases

Description

Inclusion Criteria:

  • Diagnosis with metastatic renal cell carcinoma
  • Prescription/administration of one of the IV or oral agents examined in the study

Exclusion Criteria:

  • Patients with other primary cancer diagnosis before RCC diagnosis
  • Patients with pregnancy or HIV/AIDS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with IV agents
Metastatic renal cell carcinoma patients treated with IV agents
Other: Non-Interventional
Other
Patients treated with oral agents
Metastatic renal cell carcinoma patients treated with oral agents
Other: Non-Interventional
Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 63 months
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.
Up to 63 months
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.
Up to 63 months
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.
Up to 63 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Possession Ratio (MPR) for patients treated with oral drugs used in the first-line treatment of mRCC
Time Frame: Up to 63 months
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.
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
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.
Up to 63 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Anticipated)

May 31, 2017

Study Completion (Anticipated)

May 31, 2017

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-780

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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