NCT01381614

Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (IHCIS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured patients (age \>= 18 years and \< 65 years). Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting. Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design. Analyses of health insurance claims data from a large commercially insured population will be employed in the current study. Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)	Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-06-27
• Last updated: 2013-05-13