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

NCT00942058 | Terminated

• 2 other identifiers: 08080712008-A01125-50
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Kidney Cancer; Metastatic Renal Cell Carcinoma

Keywords

biological markers; CA9 protein; metastatic conventional renal cell cancer; kidney cancer

Outcome Measures

Primary Outcomes (1)

• serum protein CA9 and mRNA CA9 level under medical treatment

  before treatment, at 1, 3, 6, 9 and 12 months

Secondary Outcomes (3)

• Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine

  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

  Before treatment, at 1, 3, 6, 9, and 12 months

• serum CA9 level basis and during the following treatment groups of the MSKCC prognostic

  Before treatment, at 1, 3, 6, 9, and 12 months

Study Arms (1)

CA9 level

Serum and urinary CA9 level

Other: Serum and urinary CA9 level

Interventions

Serum and urinary CA9 level OTHER

Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.

CA9 level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Other cancer treated

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Institut Cancérologique de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (1)

• 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.

  PMID: 18550116 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jacques TOSTAIN, MD-PhD

  CHU de Saint-Etienne

  STUDY DIRECTOR

• Nicolas MOTTET, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: July 20, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

FR (3)