Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      This is a global, multi-centre, long-term, prospective, observational study to evaluate
      treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated
      for the first time with pazopanib. The study is designed to enroll approximately 700-1000
      patients in over the course of an enrollment period of approximately 18 months.There are no
      protocol-mandated visits or procedures associated with the study. Each patient is expected to
      participate for a maximum of 30 months or until premature discontinuation (i.e., due to
      death, withdrawal of consent, lost to follow-up or study termination).
    

Detailed description: 
      This is a global, multi-centre, long-term, prospective, observational study to evaluate
      treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated
      for the first time with pazopanib. The study is designed to enroll approximately 700-1000
      patients in over the course of an enrollment period of approximately 18 months. Sites will be
      contacted and qualified by the estimated number of advanced or metastatic RCC patients
      available for enrollment annually. To the extent possible, consecutive patients meeting
      inclusion/exclusion criteria will be enrolled. Sites will be required to maintain a patient
      enrolment log of eligible patients at their treatment centres. This log will document how
      patients came to be included or excluded from the study, in order to assess the
      representativeness of the study population. The overall number of patients and sites may be
      adjusted during the study to meet enrollment goals, if needed. Eligible patients will be
      enrolled by medical oncologists and potentially by urologists experienced in the management
      of patients with RCC, if consistent with local practice. There are no protocol-mandated
      visits or procedures associated with the study. Each patient is expected to participate for a
      maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of
      consent, lost to follow-up or study termination). Follow-up information will be collected
      approximately every 3 months (a window of ± 4 weeks around the date of the suggested data
      collection will be allowed). If the patient is not seen for a regularly scheduled visit at
      that time, the site may contact the patient by telephone to solicit information regarding the
      events of interest and to limit loss to follow up. It is anticipated that frequency of
      patient assessment and imaging will differ according to local standard practice; therefore
      the quarterly data collection time points are intended to collect all assessments (with the
      date of assessment) since the previous visit date.
    

Intervention name(s): Pazopanib
Intervention type(s): Drug
Intervention description(s): Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Other intervention name(s): Votrient
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This observational studies plans to recruit from cliinics that are prescribing pazopanib to
        patients as part local standard of practice.
      
Biospecimen description: 
      Not applicable. This is a Non-interventional study collecting prospective observational data.