Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 14
- 主要终点
- Histologic diagnostic (tumor)
研究概览
简要总结
Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where 76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity is about 50%. We are conducting a multicentric prospective study to add the molecular markers in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.
Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These four markers have been reported to have a differential diagnostic value in renal tumors. MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time polymerase chain reaction (RT-PCR).
The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.
The expected results will improve the preoperative diagnostic accuracy in renal tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Clinical diagnosis of kidney tumor < 4 cm
- •Cystic kidney tumor (Bosniak > IIF)
- •Consent signed
排除标准
- •Benign tumor confirmed
- •Impossibility to do abdominal pelvic ultra-sound or abdominal thoracic scanner
- •Contraindication for renal puncture
研究组 & 干预措施
1
surgery or biopsy of the kidney tumor
干预措施: surgery or biopsy of the kidney tumor (Procedure)
结局指标
主要结局
Histologic diagnostic (tumor)
时间窗: after surgery or biopsy
次要结局
- Cytology-molecular tumor markers association diagnostic (tumor)(after surgery or biopsy)
- Molecular tumor markers association diagnostic (blood + urine)(3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy)
