Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Calculation of potential immuno-score
研究概览
简要总结
This pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples (cohort 2)
详细描述
For the experiments proposed in the project the following will be used:
Court 1: tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective); Court 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transfer to the Regina National Cancer Institute Elena, IRE-IFO.
Clinical data
The following data will be collected for each patient:
- Age, ethnicity, parity, luxury habits, level of education, marital status, height, weight, index of body mass
- Data on previous clinical history, previous gynecological-obstetric pathologies and any treatments, current comorbidities and medical therapies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Cohort 1: Oncology patients
- •Age >18 years
- •Histological diagnosis of endometrial hyperplasia with and without atypia, endometrial carcinoma endometrioid histotype at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma who undergo surgery;
- •Adequate biological material to be able to carry out the planned analyses;
- •Written informed consent (only for patients in the prospective part and/or in follow up/traceable);
- •For the retrospective part: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 36 months).
- •Cohort 2: Patients with ongoing spontaneous abortion
- •Age >18 years;
- •Diagnosis of ongoing spontaneous abortion which is subjected to an instrumental review procedure of the uterine cavity, under hysteroscopic guidance;
- •Adequate biological material to be able to carry out the analyzes previously described;
- •Written informed consent.
排除标准
- •Comorbidities not controlled with adequate medical therapy;
- •Infections of the endometrial cavity (pyometra);
- •Synchronous tumors;
- •Neoadjuvant treatments;
- •Previous radiation treatments on the pelvic region.
结局指标
主要结局
Calculation of potential immuno-score
时间窗: 36 months
Calculation of potential immuno-score for each patient, considering immune pathways, correlating the results of each patient's immuno-score with his prognosis, in terms disease-free survival and overall survival.
characterize the risk classes
时间窗: 36 months
To characterize the various risk classes, the immuno-score will be combined with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial carcinoma, to investigate whether the Microenvironmental immunological factors in endometrial cancer might allow for better stratification of patients in risk classes, with the use of Artificial Intelligence, such as Machine Learning and neural networks.
Description of genetic signatures shared between the maternal-fetal interface
时间窗: 36 months
The trial aims to describe gene signatures shared between the maternal-fetal interface and the various stages of progression of endometrial carcinoma, through transcriptomic analysis, with the aim of evaluate their functional role in the immune escape of endometrial carcinoma.Transcriptomics (RNA-seq) coupled with will be used imaging approaches (IHC) and digital pathology. Spatial techniques will be exploited transcriptomics coupled to single-cell RNA-seq to study interactions between cells in the TME and at the maternal-fetal interface. The results of each patient's immuno-score will be correlated with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer.
次要结局
未报告次要终点