Cohort Study to Evaluate the Clinical Features of Patients With Epithelial Ovarian Cancer Depending on Tumoral Mutation of BRCA or Beyond BRCA Genomic Molecular Abnormalities

ARCAGY/ GINECO GROUP137 个研究点分布在 1 个国家目标入组 1,500 人2019年12月6日

概览

简要总结

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

详细描述

This is a prospective observational French multicenter cohort in patients with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014). The objective is to constitute a clinico-biological database that allows to correlate clinical and progressive features of ovarian cancer patients based on tumor genomics and molecular detected abnormalities.

注册库

clinicaltrials.gov

开始日期

2019年12月6日

结束日期

2022年11月7日

最后更新

2个月前

研究类型

Observational

性别

Female

研究者

发起方

ARCAGY/ GINECO GROUP

责任方

Sponsor

入排标准

入选标准

•Patient older than 18 years.
•Patient with ovarian and/or primitive peritoneal and/or fallopian tubes carcinoma, histologically confirmed, with an advanced stage at diagnosis (stage III to IV FIGO 2014)
•Patient in first line therapy
•Available tumor sample fixed in formalin and included in paraffin (FFPE):
•in pre-chemotherapy, insofar as possible
•having a sufficient tumor surface, with a final cellularity of at least 20%
•Identification of a molecular genetics' cancer platform participant in GREAT and an onco-geneticists team working with the investigator team
•Patient consenting her data to be collected and submitted through an automated processing
•Patient beneficiary from the French social security

排除标准

•Patient with a mucinous ovarian carcinoma
•Patient pregnant or breastfeeding
•Patient under legal protection (guardianship or court order) or unable to consent

结局指标

主要结局

Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities

时间窗: From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years

次要结局

Correlation between treatment response and the detected tumor genetic abnormalities(Up to 10 years)
Correlation between age and the detected tumor genetic abnormalities(Baseline)
Correlation between surgery resection status and the detected tumor genetic abnormalities(Up to 10 years)
Correlation between histology status and the detected tumor genetic abnormalities(Baseline)
Correlation between FIGO stage and the detected tumor genetic abnormalities(Baseline)
Correlation between Overall survival (OS) and the detected tumor genetic abnormalities(From baseline to death, assessed up to 10 years)