Last updated:  11/03/2018 17:21:30
Incidence, Prevalence, and Symptom Burden associated with Advanced Renal Cell Carcinoma in commercially insured population (IHCIS)
Clinicaltrials.gov ID 
EudraCT ID 
Not applicable
EU CT Number 
Not applicable
Trial status 
                  Study complete
                
Study complete
Trial overview
Official title: Incidence, Prevalence, and Symptom Burden associated with Advanced Renal Cell Carcinoma in commercially insured population (IHCIS)
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
New and existing claims of metastatic renal cell carcinoma across multiple years
Timeframe: 2000 -2009 (up to 10 years)
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: 
Quantify symptom burden associated with metastatic renal cell carcinoma
Timeframe: 2000 - 2009 (up to 10 years)
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- 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”).
 
- 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
 
Inclusion and exclusion 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
 
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-09-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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