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

Metastatic Renal Cell Carcinoma Clinical Trial

— CA9CRM  

Official title:

Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00942058
• Other study ID #: 0808071
• Secondary ID: 2008-A01125-50
• Status: Terminated
• Phase: N/A
• First received: June 17, 2009
• Last updated: January 28, 2014
• Start date: June 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Kidney Cancer
• Metastatic Renal Cell Carcinoma

Intervention

Other:
• Serum and urinary CA9 level
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum protein CA9 and mRNA CA9 level under medical treatment		before treatment, at 1, 3, 6, 9 and 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	serum CA9 level basis and during the following treatment groups of the MSKCC prognostic		Before treatment, at 1, 3, 6, 9, and 12 months	No