Clinical trial NCT01381614: Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (IHCIS)
Official title: Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (IHCIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: retrospective database analysis
economic burden
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be selected from a source population consisting of all persons in the IHCIS database with one or more days of eligibility for comprehensive health benefits between January 1, 2000 and December 31, 2009.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: New and existing claims of metastatic renal cell carcinoma across multiple years
timeFrame: 2000 -2009 (up to 10 years)
measure: Cost associated with management of common severe adverse events related to 1st line treatments used in metastatic renal cell carcinoma
timeFrame: 2000 -2009 (up to 10 years)
Secondary outcomes:
measure: Quantify symptom burden associated with metastatic renal cell carcinoma
timeFrame: 2000 - 2009 (up to 10 years)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: