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

January 28, 2014 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • CLERMONT-FERRAND Cedex 01, France, 63011
        • Centre Jean Perrin
      • SAINT-ETIENNE Cedex 2, France, 42055
        • CHU de Saint-Etienne
      • Saint Priest En Jarez, France, 42270
        • Institut Cancérologique de la Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum protein CA9 and mRNA CA9 level under medical treatment
Time Frame: before treatment, at 1, 3, 6, 9 and 12 months
before treatment, at 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Before treatment, at 1, 3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Director: Jacques TOSTAIN, MD-PhD, CHU de Saint-Etienne
  • Principal Investigator: Nicolas MOTTET, MD, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (ESTIMATE)

July 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808071
  • 2008-A01125-50 (OTHER: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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