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临床试验/NCT04528940
NCT04528940Unknown不适用

Correlation Between Grade of Ovarian and Endometrial Carcinoma and the Expression of PD-1/PDL-1.

RWJ Barnabas Health at Jersey City Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining

研究概览

简要总结

Endometrial carcinoma is the most common gynecologic cancer in the western world. Two types are usually described. Type I is the endometrioid and is usually estrogen dependent. Type II is usually more aggressive than type I and is estrogen independent. Type II endometrial cancer is usually characterized as high grade while type I as low intermediate and high grade. Ovarian carcinoma as opposed to endometrial carcinoma is not characterized by types but by different histological backgrounds. It is also divided into high and low grade tumors. Ovarian carcinoma is considered to be the most aggressive of all gynecological malignancies resulting in most yearly deaths. Our immune system usually responds to foreign intruders entering our body or formed inside and attacks it in order to destroy it. Cancer cells are considered to be foreign to the body hence the immune system is expected to destroy it . The immune mediated cells which are supposed to attack the cancer are called tumor infiltrating lymphocytes or "TILS". Many different cancers possess the ability to evade TILS in order to survive and grow. Many studies have demonstrated that the presence of large number of TILS improved cancer prognosis. One of these evasive methods is the PD-1/PDL-1 expression. The question whether more aggressive tumors possess better capabilities to evade an immune response via the PD-1/PDL-1 mechanism is currently unknown. All tumor types possess antigens on their cell surface which triggers an immune response to some extent. Even though, the tumor needs different methods in order to be able to avoid the immune system attack. TILS express the PD-1 receptor on their cell surface and when it binds to PDL-1 or PDL-2, the cells which express the ligand deactivate TILS hence deem the lymphocyte incapable of inducing programmed cell death. PDL-1 which is expressed on tumor cells to evade an immune response can be targeted by immunotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All ages Endometrial carcinoma Ovarian carcinoma All grades All stages All races Female patients PD-1/PDL-1 staining positive -

排除标准

  • Any cancer which is not endometrial or ovarian Cancer which do not stain positive for PD-1/PDL-1

结局指标

主要结局

Correlation between tumor grade and prevalence of PD-1/PDL-1 histologic staining

时间窗: Through study completion, an average of 12 months

The purpose of the study is to show that the more the tumor is aggressive the higher is the prevalence of PD-1/PDL-1 staining. so every endometrial and ovarian tumors diagnosed will be stained and linear regression curves constructed to look for correlation

次要结局

未报告次要终点

研究者

发起方
RWJ Barnabas Health at Jersey City Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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