Survival Analysis in patiEnts With Bad Prognosis Epithelial Ovarian CArcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Characteristic 2 of patients
研究概览
简要总结
Ovarian carcinoma is the most lethal gynecological malignancy. Epithelial ovarian carcinoma is the gynecological malignancy with the highest mortality rate. The prognosis of patients with recurrent disease is highly heterogeneous and is typically poor in cases of ovarian carcinoma with a progression-free survival (PFS) ≤ 6 months, for which therapeutic options are limited. However, it has been shown that patients with a PFS ≤ 6 months may not respond effectively to further treatments, whereas, conversely, patients with a PFS > 6 months could still benefit from them.
The classification of patients with recurrent disease has undergone continuous evolution over time. Essential factors to consider include patient characteristics, disease stage, and the precise genetic and molecular profile of the tumor. This study aims to evaluate survival in patients experiencing recurrence of epithelial ovarian carcinoma with an unfavorable prognosis, with the objective of improving patient categorization and management.
详细描述
The study is a collection of clinical-pathological and prognostic data from patients with recurrent epithelial ovarian carcinoma with a progression-free survival of ≤ 6 months.
All patients, identified consecutively, will be registered by the investigators, after verification of the eligibility criteria.
The requested data will be recorded in a specific anonymous database. The physician will be asked to complete all the database entries that will be analyzed to evaluate the primary and secondary endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •INCLUSION CRITERIA
- •Patients diagnosed with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma with a PFS ≤6 months.
- •Age ≥18 years.
- •Any FIGO (Federation of Gynecology and Obstetrics) stage at diagnosis.
- •Signed informed consent for the use of personal data for research purposes.
- •ECOG performance status ≤
排除标准
- •Age <18 years.
- •Patients with non-epithelial ovarian carcinoma.
- •Patients with a PFS >6 months.
研究组 & 干预措施
platinum-resistant recurrence
All patients will be trated according to standard practice
结局指标
主要结局
Characteristic 2 of patients
时间窗: 2 years
Height (cm) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 1 of patients
时间窗: 2 years
Weight (Kg) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 3 of patients
时间窗: 2 years
Age (years) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 4 of patients
时间窗: 2 years
ca 125 levels (U/mL) expressed as mean and standard deviation or median and interquartile range, as appropriate.
Characteristic 5 of patients
时间窗: 2 years
Tumor stage (1-2-3-4) expressed as absolute and percentage frequency.
Characteristic 6 of patients
时间窗: 2 years
histotype (HGSOC, LGSOC, HG endometrioid, LG endometrioid, clear cell, other) expressed as absolute and percentage frequency.
Characteristic 7 of patients
时间窗: 2 years
molecular profiling (HRD positive, HRD negative) expressed as absolute and percentage frequency.
Characteristic 8 of patients
时间窗: 2 years
mutation of BRCA ½ (mutation, wild type) expressed as absolute and percentage frequency.
次要结局
- Survival data(2 years)
研究者
MARCHETTI CLAUDIA
Associate Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS