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临床试验/NCT05574673
NCT05574673招募中不适用

Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study

Nordic Society of Gynaecological Oncology - Clinical Trials Unit1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
350
试验地点
1
主要终点
Endpoint OP1

研究概览

简要总结

This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1/2 and HRD status.

详细描述

The overall objective of the study is to demonstrate the distribution of ovarian cancer by HRD and BRCA1/2 mutational status and further characterize sub-cohorts of long- and short-term responders. Additionally, to collect representative clinical samples for further translational analyses.

The overall objective is separated by two distinct observational periods defined as Observational Period 1 (OP1) and Observational Period 2 (OP2):

  • OP1: From date of diagnosis to date of first response assessment following 1L chemotherapy, progression or death, whichever occurs first
  • OP2: From date of first response assessment following 1L chemotherapy to maximum 36 months following 1L chemotherapy, death or withdrawal of consent, whichever occurs first.

Objective for Observational Period 1 (OP1) The objective for OP1 is to demonstrate the distribution of ovarian cancer patients with FIGO stage I-II BRCA1/2mut ovarian cancer, or stage III-IV ovarian cancer in cohorts of BRCA1/2, HRD (either BRCA1/2 mutation and/or genomic instability), HRP and HR-unknown patients.

Objective for Observational Period 2 (OP2) The objective for OP2 is to further characterize sub-cohorts of short-term responders (progressing < 6 months following maintenance treatment) and long-term responders (progressing ≥ 32 months following maintenance treatment) in real-world cohorts of ovarian cancer patients. For FIGO stage I-II BRCA1/2mut or FIGO stage III-IV defined by HRD status determined by Myriad myChoice® CDx HRD test or non-Myriad local HRD test, and BRCA1/2 status.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Endpoint OP1

时间窗: 36 months

Frequency of surgical resection

次要结局

  • Endpoints OP1 - 1.2(36 months)
  • Endpoints OP1 - 1.3(36 months)
  • Endpoints OP1 - 1.4(36 months)
  • Endpoint OP2 - 2.2(36 months)
  • Endpoints OP1 - 1.1(36 months)
  • Endpoint OP2 - 2.1(36 months)

研究者

发起方
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
申办方类型
Other
责任方
Sponsor

研究点 (1)

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