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

Kidney Diseases Clinical Trial

— ChemoRenCan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339975
• Other study ID #: CHUBX 2010/45
• Status: Completed
• Start date: June 6, 2011
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: May 2019
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
France	University Bordeaux Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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