Kidney Diseases Clinical Trial
— ChemoRenCanOfficial title:
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
NCT number | NCT01339975 |
Other study ID # | CHUBX 2010/45 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2011 |
Est. completion date | May 2019 |
Verified date | August 2019 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Bordeaux Hospital | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
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* Note: There are 22 references in all — Click here to view all references
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 |
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