Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer (CA9CRM)
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|ClinicalTrials.gov Identifier: NCT00942058|
Recruitment Status : Terminated (Difficult for recruiting)
First Posted : July 20, 2009
Last Update Posted : January 29, 2014
One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.
Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.
CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.
In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.
|Condition or disease||Intervention/treatment|
|Metastatic Kidney Cancer Metastatic Renal Cell Carcinoma||Other: Serum and urinary CA9 level|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Serum and urinary CA9 level
Other: Serum and urinary CA9 level
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
- serum protein CA9 and mRNA CA9 level under medical treatment [ Time Frame: before treatment, at 1, 3, 6, 9 and 12 months ]
- Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine [ Time Frame: Before treatment, at 1, 3, 6, 9, and 12 months ]
- The type and duration of clinical response based on the initial rate and the slope of decline [ Time Frame: Before treatment, at 1, 3, 6, 9, and 12 months ]
- serum CA9 level basis and during the following treatment groups of the MSKCC prognostic [ Time Frame: Before treatment, at 1, 3, 6, 9, and 12 months ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942058
|Centre Jean Perrin|
|CLERMONT-FERRAND Cedex 01, France, 63011|
|Institut Cancérologique de la Loire|
|Saint Priest En Jarez, France, 42270|
|CHU de Saint-Etienne|
|SAINT-ETIENNE Cedex 2, France, 42055|
|Study Director:||Jacques TOSTAIN, MD-PhD||CHU de Saint-Etienne|
|Principal Investigator:||Nicolas MOTTET, MD||CHU de Saint-Etienne|