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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)

Study type: Observational

Funder types: Industry

Identifiers

NCT01381614

114867

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
• Two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 [kidney metastasis]) on different days <120 days apart (the date of the earliest such encounter will be designated the "index date").

Exclusion criteria

• evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
• Evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
• Subjects with evidence of any other primary cancer

Trial design

1 participants in 1 patient group

Occurance of severe adverse event claims in subjects

Description:

Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC. Common severe adverse event defined as Grade 3 or higher with \>=5% frequency of occurance as reported in product label.

Treatment:

Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)