Clinical trial NCT00942058: Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer
Official title: Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Kidney Cancer
Metastatic Renal Cell Carcinoma
Keywords: biological markers
CA9 protein
metastatic conventional renal cell cancer
kidney cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a metastatic conventional renal cell cancer. All patients must sign a consent form to be included in this study.

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

Eligibility 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

Primary outcomes:
measure: serum protein CA9 and mRNA CA9 level under medical treatment
timeFrame: before treatment, at 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine
timeFrame: Before treatment, at 1, 3, 6, 9, and 12 months
measure: The type and duration of clinical response based on the initial rate and the slope of decline
timeFrame: Before treatment, at 1, 3, 6, 9, and 12 months
measure: serum CA9 level basis and during the following treatment groups of the MSKCC prognostic
timeFrame: Before treatment, at 1, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: CLERMONT-FERRAND Cedex 01
country: France
facility: Centre Jean Perrin
city: Saint Priest En Jarez
country: France
facility: Institut Cancérologique de la Loire
city: SAINT-ETIENNE Cedex 2
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Jacques TOSTAIN, MD-PhD
role: STUDY_DIRECTOR
affiliation: CHU de Saint-Etienne
name: Nicolas MOTTET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. Serum carbonic anhydrase 9 level is associated with postoperative recurrence of conventional renal cell cancer. J Urol. 2008 Aug;180(2):510-3; discussion 513-4. doi: 10.1016/j.juro.2008.04.024. Epub 2008 Jun 11.