Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)
9 maj 2013 uppdaterad av: GlaxoSmithKline
Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients.
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).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 64 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Study subjects will be selected from a source population consisting of all persons in the PharMetrics database with one or more days of eligibility for comprehensive health benefits between January 1, 2000 and December 31, 2009.
Beskrivning
Inclusion Criteria:
- 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
- evidence of any other primary cancer
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Severe adverse event claims in subjects with metastatic RCC
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 occurence as reported in product label.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
New and existing claims of metastatic renal cell carcinoma across multiple years
Tidsram: 2000 - 2009 (up to 10 years)
|
Identifying new and existing claims (based on claims based case-ascertainment algorithm) of metastatic renal cell carcinoma across multiple years
|
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
Tidsram: 2000 - 2009 (up to 10 years)
|
Quantifying economic burden associated with management of common severe adverse events (defined as grade 3 and above adverse events occurring >= 5% as per product label) related to agents used in 1st line metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
Adverse events will be identified based on product labels.
|
2000 - 2009 (up to 10 years)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quantify symptom burden associated with metastatic renal cell carcinoma
Tidsram: 2000 - 2009 (up to 10 years)
|
Quantifying symptom burden based on identification of claims associated with the respective symptoms.
Disease related symptoms will be identified based on published literature.
|
2000 - 2009 (up to 10 years)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2011
Primärt slutförande (Faktisk)
1 oktober 2011
Avslutad studie (Faktisk)
1 oktober 2011
Studieregistreringsdatum
Först inskickad
23 juni 2011
Först inskickad som uppfyllde QC-kriterierna
23 juni 2011
Första postat (Uppskatta)
27 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 maj 2013
Senast verifierad
1 maj 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i njurarna
- Karcinom, njurcell
- Carcinom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Sorafenib
- Sunitinib
- Bevacizumab
Andra studie-ID-nummer
- 114866
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