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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date June 17, 2009
First Posted Date July 20, 2009
Last Update Posted Date January 29, 2014
Study Start Date June 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2009)
serum protein CA9 and mRNA CA9 level under medical treatment [ Time Frame: before treatment, at 1, 3, 6, 9 and 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood, urine
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.
Condition
  • 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.
Study Groups/Cohorts CA9 level
Serum and urinary CA9 level
Intervention: Other: Serum and urinary CA9 level
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 28, 2014)
16
Original Estimated Enrollment
 (submitted: July 17, 2009)
30
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00942058
Other Study ID Numbers 0808071
2008-A01125-50 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Not Provided
Investigators
Study Director: Jacques TOSTAIN, MD-PhD CHU de Saint-Etienne
Principal Investigator: Nicolas MOTTET, MD CHU de Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date January 2014