Identification of Genetic, Phenotypic, Clinical, Biological and Histological Factors Differentiating Patients With Ovarian Cancer Who Are Refractory to Platinum-based Therapy From Patients Defined as Long-term Responders to Platinum-based Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Molecular anomalies retained after biological interpretation and allowing the differentiation of refractory patients from long-term responder patients.
研究概览
简要总结
After having constituted the ORTRAI cohort using the CONSORE database at the Jean PERRIN Center, the objective is to characterize the patients both clinically and biologically, histologically and genomically.
The clinical and biological characterizations will allow us to confirm that our cohort is comparable with data from the literature.
The complement of immunohistochemical and molecular analyses will provide more details on the differences between long-term patients responding to treatment and refractory patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Major patient, treated at the Jean Perrin Center, suffering from ovarian cancer at any stage and treated with platinum-based chemotherapy in the first line of treatment.
- •Corresponding to one of the two groups below:
- •Refractory group: patients progressing in the first therapeutic line of platinum-based chemotherapy.
- •Group of long-term responders: patients who have not progressed 5 years after the end of first-line platinum salt treatment
- •Affiliation to a social security scheme
- •Patient who signed the genetic consent form
排除标准
- •Minor patient
- •Pregnant patient
- •Patient under guardianship or conservatorship
- •Patients who object to the collection of their medical/paramedical data
- •Patient for whom the center does not have biological material for genomic analysis (FFPE block)
- •Patient under administrative, judicial decision or AME (State Medical Aid)
研究组 & 干预措施
long-term responders
molecular analysis on histological blocks
干预措施: molecular analysis (Genetic)
结局指标
主要结局
Molecular anomalies retained after biological interpretation and allowing the differentiation of refractory patients from long-term responder patients.
时间窗: Through study completion, an average of 1 year
Refractory patients are defined as any patient progressing through the first therapeutic line of platinum-based chemotherapy. Long responders are defined as any patient who has not progressed within 5 years of the end of platinum salt treatment.
次要结局
- Phenotypic criteria differences between refactory patients and long responder patients(Through study completion, an average of 1 year)
- Clinical criteria differences between refactory patients and long responder patients(Through study completion, an average of 1 year)
- Biological criteria difference between refactory patients and long responder patients(Through study completion, an average of 1 year)
- Histological criteria differences between refactory patient and long responder patients(Through study completion, an average of 1 year)