NCT07852884Active, not recruiting
First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain
Retrospective Observational Study on Clinical Outcomes and Treatment Management of First-Line Systemic Therapies in Patients With Advanced Renal Cell Carcinoma in Spain Using the BIG-PAC® Database
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- Jul 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT07852884
What you commit to
- Study type: Observational
- Planned participants: 1200
- From Jul 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in an interventional clinical trial during treatment with first-line systemic therapies that may affect clinical or safety outcomes.
Age
- Age \<18 years at the time of first-line systemic therapies initiation.
Other
- Insufficient clinical information in the electronic medical records (EMR) to evaluate the study outcomes (OS, PFS, ORR, safety).
- 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.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.