Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry
研究概览
简要总结
Evaluation of clinical, therapeutic and prognostic relevance of new experimental results as well as optimization of therapeutic models and development of a new algorithm for therapeutic plan and therapy in patients with uterine neoplasm
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Confirmed uterine malignancy ( cervical cancer, endometrial cancer, sarcoma)
- •If operable: surgical primary therapy: laparoscopic/robot-assisted or open radical gyneco-oncological surgery
- •Written consent
- •Willingness and ability to participate in all study-specific procedures
- •Age ≥ 18 years
排除标准
- •Severe and acute general disease in the last 4 weeks
- •Acute or chronic psychiatric disorders
- •Other factors questioning study participation (e.g. acute psychosocial stress, insufficient understanding of nature and consequences of the study, inadequate skills of the German language)
结局指标
主要结局
Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry
时间窗: 12 months
rate of flow of urine
Douglas cytology
时间窗: 12 months
Intraperitoneal wash fluid
Proteomic analysis
时间窗: 12 months
Analysis of proteins by mass spectrometry in removed uterine and sentinel lymph node tissue
Peripheral nerve conduction velocity
时间窗: 12 months
Intra- and interindividual comparison of N. obturatorius, N. pudendus between pre an post radical gynecological surgery
Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry
时间窗: 12 months
cm H20
DNA
时间窗: 12 months
Determination of DNA in peripheral blood
CTC and DTC analysis
时间窗: 12 months
Identification and quantification of genetic variants and mutations
HPV
时间窗: 12 months
Analysis of HPV types by DNA tests in peripheral blood, bone marrow, sentinel-lymph node, cervical-, endometrial- and myometrial-tissue, intraperitoneal wash fluid
Sentinel lymph nodes
时间窗: 12 months
Number of detectable lymph nodes by Tc99m- and indocyanine green-labeling
Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry
时间窗: 12 months
pressur/volume relationship
次要结局
未报告次要终点