Prospective Identification and Characterization of Endometrial Cancer With Specific Tumor Markers in Serum and Endometrial Tissue Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of positive H-score of HE4.
研究概览
简要总结
Endometrial cancer is the most common malignant tumor of the female genital tract in our means. The diagnosis is made by endometrial biopsy sampling with anatomopathological analysis which pinpoints the cell line and the level of cell differentiation. Its treatment is surgical with adjuvant treatment (chemotherapy or radiotherapy) besides, depending on the staging. Thus far, in the first diagnosis it is only request the tumor marker CA125 in serum, but there are studies that identify the HE4 protein in blood as a feasible marker for endometrial cancer. Furthermore, the staging changes the surgical and the adjuvant treatment: in its early stages, surgery is based on hysterectomy and double adnexectomy, however, in later stages it is necessary to add pelvic and paraaortic lymphadenectomy with the associated comorbidity. This makes extremely important that the preoperative diagnosis is accurate. The aim of this study is to identify and characterize the HE4, Ki67, p53 and other potential biomarkers in endometrial tissue in order to diagnose patients with disease only with a biopsy. Moreover, the investigators are searching for connections among these markers and prognostic factors such as grade of cell differentiation, cell line, lymphatic affectation, tumor stage or even features as survival or disease free survival.
详细描述
List of abbreviations:
- HE4: Human Epididymis Protein 4
- CA125: Carbohydrate Antigen 125
- Ki67: antigen KI67
- EC: Endometrial Cancer
- CT: Computed Tomography
- NMR: Nuclear Magnetic Resonance
- FIGO: International Federation of Gynecology and Obstetrics
The purpose of this study is:
- The proportion of positive H-score of HE4, as quantified in endometrial tissue. It is significantly higher in patients with endometrial cancer than in non-EC patients.
- Percentage of HE4, CA125 and other markers positives in cases and controls.
- Concentration of HE4 in tissue, as measured by H-score, correlates linearly with HE4 concentration in serum, as measured in terms of ppmol/l.
- Differences in serum CA125 levels between cases and controls.
- Quantification of tissue tumor markers of EC patients, per disease stages.
- Relation of the immunohistochemistry intensity with survival and disease-free survival times.
- Analysis of other risk factors adjusting for known variables like age, menopausal status, hypertension, diabetes or obesity.
- Feasibility of the technique.
Steps in the study:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Of legal age (≥ 18 years)
- •Wish to participate in the research study and sign consent forms voluntarily
- •Patients diagnosed of endometrial cancer derived to hysterectomy
排除标准
- •Patients that underwent surgery for other malignant pathologies, whether for ovarian carcinoma, cervical carcinoma or uterine sarcoma.
结局指标
主要结局
The proportion of positive H-score of HE4.
时间窗: Two years
HE4 quantified in endometrial tissue is significantly higher in patients with endometrial cancer than in non-EC patients
次要结局
- Disease stages(Two years)
- Tissue tumor marker HE4(Two years)
- Analysis of outcomes in relation to diabetes(Two years)
- Analysis of outcomes in relation to obesity(Two years)
- Difference in preoperative serum CA125 levels in cases and controls.(Two years)
- Difference in preoperative serum HE4 levels in cases and controls.(Two years)
- Analysis of outcomes in relation to age(Two years)
- Concentration of HE4 in tissue correlates linearly with HE4 in serum.(Two years)
- Relation of the immunohistochemistry intensity in H-score with overall survival(Through study completion, an average of 2 years)
- Relation of the immunohistochemistry intensity in H-score with disease-free survival(Through study completion, an average of 2 years)
- Analysis of outcomes in relation to hypertension(Two years)
- Analysis of outcomes in relation to menopausal status(Two years)
研究者
Tatiana Cuesta-Guardiola
Principal investigator
Fundación Investigación Sanitaria en León