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Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer (CA9CRM)

This study has been terminated.
(Difficult for recruiting)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00942058
First received: June 17, 2009
Last updated: January 28, 2014
Last verified: January 2014

June 17, 2009
January 28, 2014
June 2009
November 2013   (final data collection date for primary outcome measure)
serum protein CA9 and mRNA CA9 level under medical treatment [ Time Frame: before treatment, at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00942058 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer
Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood, urine

Non-Probability Sample

Patients with a metastatic conventional renal cell cancer. All patients must sign a consent form to be included in this study.

  • Metastatic Kidney Cancer
  • Metastatic Renal Cell Carcinoma
Other: Serum and urinary CA9 level
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
CA9 level
Serum and urinary CA9 level
Intervention: Other: Serum and urinary CA9 level
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. Epub 2008 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Other cancer treated
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00942058
0808071, 2008-A01125-50
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Study Director: Jacques TOSTAIN, MD-PhD CHU de Saint-Etienne
Principal Investigator: Nicolas MOTTET, MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP