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
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Blood, urine


Enrollment: 16
Study Start Date: June 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942058

Locations
France
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
Investigators
Study Director: Jacques TOSTAIN, MD-PhD CHU de Saint-Etienne
Principal Investigator: Nicolas MOTTET, MD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00942058     History of Changes
Other Study ID Numbers: 0808071, 2008-A01125-50
Study First Received: June 17, 2009
Last Updated: January 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
biological markers
CA9 protein
metastatic conventional renal cell cancer
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014