Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Presence of lymph node metastases
研究概览
简要总结
The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.
详细描述
This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.
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
- 否
入选标准
- •Women with endometrial carcinoma
- •Available endometrial biopsy
- •Informed consent
排除标准
- •No informed consent
结局指标
主要结局
Presence of lymph node metastases
时间窗: At primary treatment
次要结局
- Recurrent disease, death from disease(5 years after primary treatment)
研究者
Helga B Salvesen
Professor, MD, PhD
University of Bergen