Last updated: 11/03/2018 17:21:30

Incidence, Prevalence, and Symptom Burden associated with Advanced Renal Cell Carcinoma in commercially insured population (IHCIS)

GSK study ID
114867
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Drug: Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
March 2011 to December 2011
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
  • 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

Trial location(s)

No location data available.

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
Finalized
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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