Observational Prospective Study to Analyze a Metabolomic Profile and to Explore it as Prognostic Factor in Patients With Renal Cell Carcinoma (mRCC)

Antiangiogenics are the mainstay of treatment in patients with metastatic renal cell carcinoma. Conventional clinical end-points, used to measure efficacy with chemotherapeutic agents, have not been helpful in monitoring the efficacy of antiangiogenic therapy. Increasing numbers of predictive and pharmacodynamic biomarkers are being investigated that are useful surrogates for clinical response and also to identify patients early on who will benefit from this class of agents. This is valuable in avoiding unnecessary toxicity in patients and also in reducing cost implications of this expensive group of drugs.

The investigators wish to explore the variability of baseline metabolomic profile in the blood and urine of patients with mRCC and characterise the inter-subject and intra-subject variability. The study of the baseline levels has not been performed in this cohort previously. This is extremely important in interpreting the emerging data of changes in the levels of the various biomarkers from various trials. This will in turn help in the development of future targeted therapies, especially Phase I/II studies where an early demonstration of target modulation is vital. This study will also help to identify the number of patients required for appropriate statistical evaluation in pharmacodynamic studies to assess biological activity, optimisation of dosing, and investigation of potential mechanisms of resistance. Study of the urinary and blood metabolomic profile in conjunction will give us an insight into the potential use of urine as a diagnostic and prognostic tool.

OBJECTIVES GOAL The main objective of the study is to determine the change from baseline in metabolomic profiling in patients with clear cell renal cell carcinoma 1 month after nephrectomy or antiangiogenic treatment during 2 months