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

Completed

• Conditions: Kidney Neoplasms; Chemokines; Carcinoma; Carcinoma Renal Cell; Kidney Diseases
• Interventions: Biological: Biological sample

• Registration Number: NCT01339975
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Study Start: 2011-06-06
• Primary Completion: 2014-05
• Study Completion: 2019-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A. Surgically treated patients	Biological sample	Patients having a radical or partial nephrectomy.
Group B. Patients treated with targeted therapies	Biological sample	Patients treated by RCC-directed targeted therapy

Primary Outcome Measures

Name	Time	Method
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)	3 years	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

Secondary Outcome Measures

Name	Time	Method
Predictive value of therapeutic response	3 years	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

Trial Locations

Locations (1)

University Bordeaux Hospital; 🇫🇷 Bordeaux, France