Active, not recruiting
Observational
First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain
Condition(s) studied
Renal Cell Carcinoma (RCC)
Investigational drug(s) / intervention(s)
First-line systemic regimens
First-line systemic regimens: First-line systemic regimens for advanced or metastatic renal cell carcinoma include: nivolumab plus ipilimumab, axitinib plus avelumab, axitinib plus pembrolizumab, lenvatinib plus pembrolizumab, cabozantinib plus nivolumab, cabozantinib, tivozanib, sunitinib, and pazopanib
Study summary
This retrospective observational study will use anonymized electronic medical records from the BIG-PAC® database to describe outcomes and treatment management for adults in Spain with advanced or metastatic renal cell carcinoma who start first-line systemic therapy.
Eligibility
Inclusion Criteria:
* Age ≥18 years at the index date.
* Documented diagnosis of advanced renal cell carcinoma (aRCC) identified through International Classification of Diseases (ICD) 9 codes recorded in medical history
* Initiation of first-line systemic therapies within the study selection period (January 1, 2019, to December 31, 2024).
* A minimum of 12 months of follow-up data available after the index date, unless the participant dies earlier.
* Availability of sufficient clinical data for evaluation of primary endpoints \[overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), time to response (TTR), safety).
* Documented clinical follow-up at the treating center during first-line systemic therapies and at least one post-treatment initiation follow-up record.
* Note: International Metastatic RCC Database Consortium (IMDC) classification is not an inclusion criterion; IMDC intermediate/poor defines the primary analysis cohort
Exclusion Criteria:
* Insufficient clinical information in the electronic medical records (EMR) to evaluate the study outcomes (OS, PFS, ORR, safety).
* Participation in an interventional clinical trial during treatment with first-line systemic therapies that may affect clinical or safety outcomes.
* Receipt of first line treatments outside routine clinical practice, such as compassionate use, expanded access, or off-label administration when relevant to the study objectives.
* Diagnosis is inconsistent with advanced or metastatic RCC, including non-epithelial renal tumors or histology not aligned with the study population.
* Age \<18 years at the time of first-line systemic therapies initiation.
* If additional data-driven exclusions are identified during data validation, they may be described in the Statistical Analysis Plan (SAP) but will not be added as protocol-defined criteria.
Primary outcome measure(s)
- Overall survival from index date to death from any cause — Up to 7 years
Trial sites (1)
| Facility | City | Region | Status |
| Local Institution - 0001 |
Madrid |
Spain |
|
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