Clinical trial NCT01339975: Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
Official title: Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Carcinoma Renal Cell
Kidney Neoplasms
Kidney Diseases
Chemokines
Keywords: Renal Cell Carcinoma
Nephrectomy
Antiangiogenics
Chemokines
Prognostic value
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)
timeFrame: 3 years
Secondary outcomes:
measure: Predictive value of therapeutic response
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Bordeaux Hospital
Study officials:
affiliation: University Hospital Bordeaux, France
name: Jean-Christophe BERNHARD, Dr
role: PRINCIPAL_INVESTIGATOR
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