Overview

This trial is active, not recruiting.

Conditions carcinoma, carcinoma renal cell, kidney neoplasms, kidney diseases, chemokines
Treatments biological sample
Sponsor University Hospital, Bordeaux
Start date June 2011
End date May 2014
Trial size 310 participants
Trial identifier NCT01339975, CHUBX 2010/45

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients having a radical or partial nephrectomy.
biological sample
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.
Patients treated by RCC-directed targeted therapy
biological sample
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.

Primary Outcomes

Measure
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)
time frame: 3 years

Secondary Outcomes

Measure
Predictive value of therapeutic response
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
Principal investigator Jean-Christophe BERNHARD, Dr
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.