Last updated: 02/04/2020 15:50:19

Patterns of Care for Patients with Metastatic Renal Cell Carcinoma in a United States Population

GSK study ID
201379
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Patterns of Care for Patients with Metastatic Renal Cell Carcinoma in a United States Population
Trial description: GlaxoSmithKline (GSK) and Humana are interested in studying real-world treatment patterns of first- (1L) and second-line (2L) therapies among patients treated for metastatic renal cell carcinoma (mRCC). Humana is interested in understanding real-world treatment patterns experienced by their members and comparing those treatment patterns to national guidelines and across the sites of care through which therapies are being delivered.
The primary objective of this study is to describe the patterns of treatment associated with systemic therapies for mRCC, including persistence and compliance for 1L, and where applicable 2L therapies. The secondary objectives are to describe the clinical and demographic characteristics of patients with mRCC stratified by initial therapy regimen (1L) and to describe initial mRCC therapy regimen by prescriber specialty and site of care.
The data source for this study will be Humana’s administrative claims, and the design of this study will be a retrospective database analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Treatment Patterns

Timeframe: 6 years

Secondary outcomes:

Subject Characteristics

Timeframe: 6 years

First Line Treatment Regimen

Timeframe: 6 years

Interventions:
  • Drug: bevacizumab
  • Drug: temsirolimus
  • Drug: Interferon alfa-2b
  • Drug: sorafenib
  • Drug: axitinib
  • Drug: pazopanib
  • Drug: sunitinib
  • Drug: everolimus
  • Drug: Interferon alfa-2a
  • Drug: interleukin-2 (aldesleukin)
    • Enrollment:
    0
    Primary completion date:
    2014-25-07
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Humana
    Study date(s)
    March 2014 to July 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 89 Year
    Accepts healthy volunteers
    none
    • Age 18 to 89 years as of the index date
    • Continuous enrollment and fully-insured status in a Humana health plan for the 180-day pre-index date period and the 180-day post-index date period
    • Age less than 18 years or older than 89 years
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Age 18 to 89 years as of the index date
    • Continuous enrollment and fully-insured status in a Humana health plan for the 180-day pre-index date period and the 180-day post-index date period
    • At least two claims with a primary diagnosis for renal carcinoma (ICD-9-CM 189.0 – malignant neoplasm of kidney, except pelvis and/or 189.1 – malignant neoplasm of renal pelvis), at least 30 days apart and occuring between July 1, 2007 and June 30, 2013
    • Evidence of advanced disease: at least 1 claim with a diagnosis of metastatic disease (ICD-9-CM 196.xx-199.xx – secondary malignant neoplasm) between July 1, 2007 and June 30, 2013. At least one primary renal carcinoma diagnosis code must have appeared prior to or on the same date as the claim with the metastatic diagnosis
    • Initiation of a systemic therapy for renal cell carcinoma after establishing a diagnosis of mRCC, i.e. at least one renal carcinoma ICD-9-CM diagnosis code of 189.0 or 189.1 AND at least one metastastic ICD-9-CM diagnosis code of 196.xx – 199.xx has to occur prior to initiation of a systemic therapy for mRCC
    Exclusion criteria:
    • Age less than 18 years or older than 89 years

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2014-25-07
    Actual study completion date
    2014-25-07

    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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