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

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ClinicalTrials.gov Identifier: NCT00942058
Recruitment Status : Terminated (Difficult for recruiting)
First Posted : July 20, 2009
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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
Metastatic Kidney Cancer Metastatic Renal Cell Carcinoma Other: Serum and urinary CA9 level

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

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study
Study Start Date : June 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Group/Cohort 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.

Primary Outcome Measures :
  1. serum protein CA9 and mRNA CA9 level under medical treatment [ Time Frame: before treatment, at 1, 3, 6, 9 and 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Biospecimen Retention:   Samples Without DNA
Blood, urine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Other cancer treated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942058

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Centre Jean Perrin
CLERMONT-FERRAND Cedex 01, France, 63011
Institut Cancérologique de la Loire
Saint Priest En Jarez, France, 42270
CHU de Saint-Etienne
SAINT-ETIENNE Cedex 2, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
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Study Director: Jacques TOSTAIN, MD-PhD CHU de Saint-Etienne
Principal Investigator: Nicolas MOTTET, MD CHU de Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00942058    
Other Study ID Numbers: 0808071
2008-A01125-50 ( Other Identifier: AFSSAPS )
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
biological markers
CA9 protein
metastatic conventional renal cell cancer
kidney cancer
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases