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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Plasma level of the MMP2 and MMP9 markers
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Plasma level of the MMP2 and MMP9 markers
时间窗: at initial sampling
ELISA assay
Survival without progression
时间窗: Up to 18 months
date of progression (RECIST criteria), date of death
次要结局
未报告次要终点