Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer

Terminated

• Conditions: Metastatic Renal Cell Carcinoma; Metastatic Kidney Cancer
• Interventions: Other: Serum and urinary CA9 level

• Registration Number: NCT00942058
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

We propose a pilot study of CA9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. This pilot study aims to test the CA9 serum marker of response to medical treatment

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Conventional renal cell cancer with a pathological diagnosis
• Metastatic disease
• Consent form signed
• social security regimen affiliated

Exclusion Criteria

• Other cancer treated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CA9 level	Serum and urinary CA9 level	Serum and urinary CA9 level

Primary Outcome Measures

Name	Time	Method
serum protein CA9 and mRNA CA9 level under medical treatment	before treatment, at 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine	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	Before treatment, at 1, 3, 6, 9, and 12 months
serum CA9 level basis and during the following treatment groups of the MSKCC prognostic	Before treatment, at 1, 3, 6, 9, and 12 months

Trial Locations

Locations (3)

Centre Jean Perrin; 🇫🇷 CLERMONT-FERRAND Cedex 01, France

Institut Cancérologique de la Loire; 🇫🇷 Saint Priest En Jarez, France

CHU de Saint-Etienne; 🇫🇷 SAINT-ETIENNE Cedex 2, France