Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer
NCT ID: NCT00942058
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
16 participants
OBSERVATIONAL
2009-06-30
2013-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CA9 level
Serum and urinary CA9 level
Serum and urinary CA9 level
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
Interventions
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Serum and urinary CA9 level
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease
* Consent form signed
* social security regimen affiliated
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jacques TOSTAIN, MD-PhD
Role: STUDY_DIRECTOR
CHU de Saint-Etienne
Nicolas MOTTET, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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Centre Jean Perrin
Clermont-Ferrand, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Institut Cancérologique de la Loire
Saint-Priest-en-Jarez, , France
Countries
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References
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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.
Other Identifiers
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2008-A01125-50
Identifier Type: OTHER
Identifier Source: secondary_id
0808071
Identifier Type: -
Identifier Source: org_study_id
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