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

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ClinicalTrials.gov Identifier: NCT01339975
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date April 20, 2011
First Posted Date April 21, 2011
Last Update Posted Date August 5, 2019
Actual Study Start Date June 6, 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01339975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 20, 2011)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, urine and tissues
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma
Condition
  • Carcinoma
  • Carcinoma Renal Cell
  • Kidney Neoplasms
  • Kidney Diseases
  • Chemokines
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: 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.
Study Groups/Cohorts
  • Group A. Surgically treated patients
    Patients having a radical or partial nephrectomy.
    Intervention: Biological: Biological sample
  • Group B. Patients treated with targeted therapies
    Patients treated by RCC-directed targeted therapy
    Intervention: Biological: Biological sample
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: April 20, 2011)
310
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2019
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01339975
Other Study ID Numbers CHUBX 2010/45
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Christophe BERNHARD, Dr University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date August 2019