跳至主要内容
临床试验/NCT03954171
NCT03954171招募中不适用

Platino-resistance in Ovarian Cancer

Institut Claudius Regaud1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
The rate of patients alive without progression

研究概览

简要总结

Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages).

Patients will receive treatment (platinum based-chemotherapy) according to the standard practices.

A prospective database and an associated biological collection will be performed during 5 years:

  • For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
  • Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study).

Study participation of each patient will be 5 years.

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

入选标准

  • Age ≥ 18 years old
  • Epithelial ovarian cancer at initial diagnosis (all stages)
  • Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
  • Indication of platinum based-chemotherapy
  • Patient affiliated to the french social security system
  • Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

排除标准

  • Non-epithelial ovarian tumor, borderline ovarian tumor
  • Patient with recurrent disease
  • Exploratory surgery not performed at the "Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT-O)"
  • Pregnant or breastfeeding women
  • Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

结局指标

主要结局

The rate of patients alive without progression

时间窗: 5 years for each patient

次要结局

  • The time to onset of platinum based-chemotherapy resistance(5 years for each patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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