跳至主要内容
临床试验/NL-OMON56928
NL-OMON56928尚未招募不适用

Selecting Ovarian Cancer patients for PARP Inhibitor (SOPI) study - SOPI study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 778 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
778

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • For biopsy:
  • - Women with suspected EOC, aged 18 years or older who give informed consent
  • for routine diagnostics including the sample for the HRD tests. In a
  • subpopulation we will compare HRD tests on tissue obtained at interval CRS as
  • - Written informed consent
  • For Follow-up PARP-i:
  • - Patients with FIGO Stage III and IV EOC cancer who received standard of care
  • with debulking surgery and platinum based chemotherapy and are eligible for
  • PARP-i according to at least one positive HRD test.
  • - Patients with germline or somatic BRCA1/2 pathogenic variants in the tumor
  • will be asked to participate as (positive) controls
  • - Patients without BRCA1/2 pathogenic variant or HRD: only registration of PFS,
  • QOL and OS.
  • Control group:
  • - Included in the PlaComOv study (MEC-2017-500/NL62035.078.17) and given
  • informed consent for the use of data for future research.

排除标准

  • - Impossibility to obtain HRD test
  • - Other diagnosis than epithelial ovarian cancer
  • - Mucinous, low grade serous or clear cell type ovarian cancer
  • - Ineligibility for PARP-i treatment: such as (but not exclusive)
  • o Not reached at least partial response to neoadjuvant chemotherapy
  • o FIGO stage I-II disease
  • o All HRD tests negative and no BRCA 1/2 carrier
  • - Patients who are not able to understand/sign the Informed Consent.
  • - Known germline BRAC1/2 mutation

研究者

相似试验