CA9CRM: Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CA9 level 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.
|
Outcome Measures
Primary Outcome Measures
- serum protein CA9 and mRNA CA9 level under medical treatment [before treatment, at 1, 3, 6, 9 and 12 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Conventional renal cell cancer with a pathological diagnosis
-
Metastatic disease
-
Consent form signed
-
social security regimen affiliated
Exclusion Criteria:
- Other cancer treated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Jean Perrin | CLERMONT-FERRAND Cedex 01 | France | 63011 | |
| 2 | Institut Cancérologique de la Loire | Saint Priest En Jarez | France | 42270 | |
| 3 | CHU de Saint-Etienne | SAINT-ETIENNE Cedex 2 | France | 42055 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Study Director: Jacques TOSTAIN, MD-PhD, CHU de Saint-Etienne
- Principal Investigator: Nicolas MOTTET, MD, CHU de Saint-Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
- 0808071
- 2008-A01125-50