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

NCT ID: NCT00942058

Last Updated: 2014-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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

Conditions

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Metastatic Kidney Cancer Metastatic Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CA9 level

Serum and urinary CA9 level

Serum and urinary CA9 level

Intervention Type OTHER

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

Interventions

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Serum and urinary CA9 level

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other cancer treated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques TOSTAIN, MD-PhD

Role: STUDY_DIRECTOR

CHU de Saint-Etienne

Nicolas MOTTET, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Institut Cancérologique de la Loire

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 18550116 (View on PubMed)

Other Identifiers

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2008-A01125-50

Identifier Type: OTHER

Identifier Source: secondary_id

0808071

Identifier Type: -

Identifier Source: org_study_id

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