Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Study Overview
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Brief Summary
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Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research. The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Detailed Description
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Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management. Therefore the identification of new molecular biomarkers is important: to improve the precision of prognostic models currently based on clinical, biological or histopathological variables to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.

Official Title
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Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Conditions
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Carcinoma, Carcinoma Renal Cell, Kidney Neoplasms, Kidney Diseases, Chemokines

Intervention / Treatment
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* Biological: Biological sample
* Biological: Biological sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma : having a radical or partial nephrectomy or treated by RCC-directed targeted therapy Patients who have signed and dated an informed consent form with the investigator Exclusion Criteria: under 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A. Surgically treated patients<br>Patients having a radical or partial nephrectomy. | Biological: Biological sample<br>* 2 blood samples of 10mL + one urine sample on pre-operative d-1/d, post-operative d1 and d5(+/-2), one month post-operative, at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.<br>|
| Group B. Patients treated with targeted therapies<br>Patients treated by RCC-directed targeted therapy | Biological: Biological sample<br>* 2 blood samples of 10mL + one urine sample before starting the therapy at first therapeutic evaluation (2 or 3 months depending on the treatment chosen) at the end of the study or at the date of disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) | Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence. Localized or locally advanced renal cell carcinoma group: local recurrence contralateral recurrence extra-renal distant recurrence (metastatic progression) specific cancer death nonspecific cancer death Metastatic renal cell carcinoma group : local recurrence for patients who underwent a nephrectomy contralateral reccurence metastatic progression specific cancer death nonspecific cancer death | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of therapeutic response | Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response. RECIST criteria: patients showing a complete response or a partial response, will be considered as responders The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephrectomy, Prognostic value, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urologic Diseases, Adjuvants, Immunologic, Physiological Effects of Drugs, Pharmacologic Actions, Biomarkers, Targeted therapies, Surgery, Renal Cell Carcinoma, Antiangiogenics, Chemokines, Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases