Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Predictive value of the model
研究概览
简要总结
The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).
These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.
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
- 是
入选标准
- •Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade)
- •FIGO stage IA-IB
- •Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format
- •Availability of preoperative US images in dicom (.dcm) format
- •Availability of preoperative CT-scan images in dicom (.dcm) format (optional)
- •Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)
排除标准
- •Metastatic cancer to the uterus (not primary EC)
- •Uterine sarcoma
- •Conservative surgery
- •FIGO stage > II
- •Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available
- •Patients without available MRI, US or CT-scan images on digital media
- •Clinical information not available or incomplete
- •Any other malignancy in the previous 5 years or synchronous
- •Patients aged under 18 years
结局指标
主要结局
Predictive value of the model
时间窗: up to one year
Receiver operating characteristic (ROC) curve and 95% confidence interval (CI) will be performed to determine cut-off values for the studied quantitative variables.
次要结局
- Validity of the model(up to one year)
研究者
Fanfani Francesco
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS