Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents

Study Overview
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Brief Summary
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Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or Pazopanib).

Detailed Description
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The objective is to analyze the predictive impact of circulating MMP2 and MMP9 on the progression-free survival of patients with metastatic kidney cancer treated with anti-angiogenic agents (Sunitinib or Pazopanib) in comparison with two untreated cohorts (localized or oligometastatic cancer). Prospective monocenter, open-label study In the frame of disease management blood samples will be collected at different times of follow-up regarding disease status (localized, oligometastatic and metastatic) and tissue samples will be collected for patients scheduled for surgery.

Official Title
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Study of the Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents Compared to Patients Not Treated With Antiangiogenic (Localized Kidney Cancer and Oligometastatic)

Conditions
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Kidney Cancer

Intervention / Treatment
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* Procedure: Blood and tumor samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient male or female, aged of more than 18 years Patient with any of the following conditions: Kidney cancer localized at diagnosis. Metastatic kidney cancer when anti-angiogenic therapy is initiated by Sunitinib or Pazopanib Oligometastatic kidney cancer without systemic treatment (local treatment) ECOG = 0 to 2 Patient affiliated to, or beneficiary of, the national social security. Patient having signed informed consent Exclusion Criteria: Patient previously treated with anti-angiogenic agents. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons 4. History of malignant disease in the 5 years prior to inclusion (except basal cell carcinoma of the skin or epithelioma of the cervix in situ, or prostate cancer with a good prognosis (stage T <3 and Gleason <7)) accidentally discovered during the histological analysis of the tumor sample. 5- Pregnant or nursing women 6- Contraindications to the procedure of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kidney cancer<br>Localized, oligometastatic or metastatic | Procedure: Blood and tumor samples<br>* Blood and tumor samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of the MMP2 and MMP9 markers | ELISA assay | at initial sampling | 
| Survival without progression | date of progression (RECIST criteria), date of death | Up to 18 months |