Non-Invasive Diagnostics of Small Renal Masses
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Expression of mRNA and DNA markers
研究概览
简要总结
NiSAR is a Ph.D. study and consists of three substudies. Renal cancer is one of the most deadly urologic malignancies and accounts for 900 new cases and 300 deaths per year. An increase in the use of imaging diagnostics has yielded a rise in the incidental detection of small renal masses (SRM), meaning tumors <4cm (T1a). Kidney biopsies are the gold standard for diagnosing SRM but has an inherent risk of infections, retroperitoneal bleeding and in rare cases loss of kidney function. This is problematic since up to 30% of SRM are benign.
This Ph.D. consists of three studies that all aim to develop new minimally invasive modalities for diagnosing SRM. Patients eligible for these studies are diagnosed with SRM at one of the departments of Urology in the southern region of Denmark. Studies 1 and 2 aims to find circulating biomarkers, in the form of DNA and messenger ribonucleic acid (mRNA) contained in micro vesicles secreted into blood by renal cell cancers and find changes in biomarkers levels after surgery. Study 3 aim to determine the potential of multiplanar MRI (mpMRI) to discriminate between benign and malign SRM. Potentially this can lead to a fundamental change of the way urologists diagnose and monitor SRM and renal cell cancer in general.
The investigators will also build a research biobank for future research.
详细描述
Study 1:
Trial objective:
Identification of biomarkers in blood and urine and to set the basis for a minimally invasive diagnostic program for SRM.
Method:
Sample collection:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients with SRM < 4cm (T1a) at the Departments of Urology in the region of Southern Denmark.
- •Written consent
- •Able to speak and understand Danish
排除标准
- •Patients below 18 years of age,
- •Patients with mental impairment
- •Withdrawal of consent
- •Other malignancies.
- •Specific for study 2:
- •Patients unsuitable for curative treatment.
- •Specific for study 3:
- •Pregnancy
- •Kidney failure
- •Kidney-grafts
- •History of allergic-reactions to contrast agents
- •Patients with non-MRI-compatible components
- •Patients unable to cooperate for an MRI.
结局指标
主要结局
Expression of mRNA and DNA markers
时间窗: Baseline
Expression levels of the sequences identified, in blood and urine will be compared by means of Whitney U test and Kruskal-Wallis test.
Change in mRNA and DNA markers
时间窗: 1 month, and 6 months
Changes in levels of expression from pre-operative to post-operative will be evaluated with Friedman´s ANOVA and subsequent post-hoc pairwise comparison with Wilcoxon's signed rank test with Bonferroni correction
Analysis of MpMRIs
时间窗: Baseline
A specialist radiologist will examine the scans in a blinded fashion, meaning that he will be ignorant to the pathologist´s diagnosis.
次要结局
- Expression of mRNA and DNA markers(Fourteen days after first samples)
研究者
Anders Ullmann Kiis Frey
Principal investigator
Odense University Hospital