Trial record 6 of 290 for:    Open Studies | "Kidney Neoplasms"

Chemokines and Renal Cancer (ChemoRenCan)

This study is currently recruiting participants.
Verified January 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01339975
First received: April 20, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Carcinoma
Carcinoma Renal Cell
Kidney Neoplasms
Kidney Diseases
Chemokines
Biological: Biological sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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:
  • Predictive value of therapeutic response [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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


Biospecimen Retention:   Samples With DNA

whole blood, urine and tissues


Estimated Enrollment: 310
Study Start Date: June 2011
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A. Surgically treated patients
Patients having a radical or partial nephrectomy.
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.
Group B. Patients treated with targeted therapies
Patients treated by RCC-directed targeted therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339975

Contacts
Contact: Alain RAVAUD, Pr (33) 05.56.79.58.08 alain.ravaud@chu-bordeaux.fr

Locations
France
University Bordeaux Hospital Recruiting
Bordeaux, France, 33076
Contact: Jean-Christophe BERNHARD, Dr       jean-christophe.bernhard@chu-bordeaux.fr   
Principal Investigator: Jean-Christophe BERNHARD, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-Christophe BERNHARD, Dr University Hospital Bordeaux, France
Study Chair: Adélaïde DOUSSAU, Dr Bordeaux University Hospital
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01339975     History of Changes
Other Study ID Numbers: CHUBX 2010/45
Study First Received: April 20, 2011
Last Updated: January 31, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Kidney Neoplasms
Renal Cell Carcinoma
Nephrectomy
Antiangiogenics
Chemokines
Prognostic value
Carcinoma
Carcinoma, Renal Cell
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Adjuvants, Immunologic
Physiological Effects of Drugs
Pharmacologic Actions
Biomarkers
Targeted therapies
Surgery

Additional relevant MeSH terms:
Kidney Neoplasms
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Adjuvants, Immunologic
Physiological Effects of Drugs
Immunologic Factors
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014