Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.
研究概览
简要总结
Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •(i) preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age >= 18 years; (v) signed informed consent for research purposes.
排除标准
- •(i) consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.
研究组 & 干预措施
Radiomics analysis and molecular/genomic profiling
This prospective single-arm observational study. Patients with newly diagnosed endometrial cancer have an ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. Then patients have surgery followed by molecular/genomic evaluation. We correlate radiomic features with molecular/genomic profiling.
干预措施: Radiomics (Diagnostic Test)
结局指标
主要结局
To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.
时间窗: 1-18 months
Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors.
时间窗: 1-36 months
次要结局
- Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors(19-36 months)
研究者
Valentina Chiappa
M.D.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano