Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- number of slides stained positive to PDL1 marker
研究概览
简要总结
the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC. Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by immunohistochemistry, and results were correlated to prognosis.
详细描述
this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites, recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The investigator followed the clinical outcomes in the form of disease free survival (DFS) and overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were calculated from the time of diagnosis to death. DFS is the time from the end of therapy to first recurrence or metastases. the specimens were stained with PDL1 marker in pathology department Port Said university.
Statistical analysis
Data was analyzed using SPSS software V.16. Continuous data was presented in the form of mean (SD) or Median (min-max) according to the results of Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data will be presented in the form of frequencies and percentages. Statistical significance will be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will be performed for categorical data (with respect to the minimal expected values in the contingencies tables). Correlations of different tumour markers will be calculated using Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and disease free survival of patients with respect to tumour expression of PDL1. Comparisons will be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with primary ovarian cancer
排除标准
- •patients with metastatic ovarian cancer
结局指标
主要结局
number of slides stained positive to PDL1 marker
时间窗: 7 years from 2012 to 2019
using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor
次要结局
- correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma(7 years from 2012 to 2019)
研究者
Mayada saad
Lecturer of pathology
Port Said University hospital