From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Validate the differential expression of LOX-1 and NALP3 receptors.
研究概览
简要总结
Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.
详细描述
The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age >18 years;
- •Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid 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 that are subjected to surgery;
- •Adequate biological material to be able to carry out the analyzes previously described;
- •Written informed consent (only for patients in the prospective part and/or in follow-up);
- •For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data.
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
Validate the differential expression of LOX-1 and NALP3 receptors.
时间窗: 36 months
Validate the differential expression of LOX-1 and NALP3 receptors at different steps progression of endometrial cancer; identify immune signatures shared between using transcriptomics the maternal-fetal interface and the different stages of progression of endometrial cancer; investigate their role functional in the immune escape process in endometrial carcinoma and/or in the pro-inflammatory response.
次要结局
- Characterize phenotypic alterations.(36 months)
- Evaluate the predictive and/or prognostic value.(36 months)