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

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.

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Key information

Conditions

Carcinoma Adenocarcinoma Carcinoma Renal Cell Carcinoma, Renal Cell Chemokines Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Bordeaux Hospital

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological sample

Biological

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.

Primary outcomes

Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)

Time frame: 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 outcomes

Predictive value of therapeutic response

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ChemoRenCan

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2019
First posted: Apr 21, 2011
Registry last updated: Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed