Genomic BRCA and Extensive ovArian Cancer Testing

Completed

• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Peritoneal Cancer

• Registration Number: NCT04027868
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Study Start: 2019-12-06
• Primary Completion: 2022-11-07
• Study Completion: 2022-11-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Progression Free Survival (PFS) and the detected tumor genetic abnormalities	From baseline until the date of progression or death, which ever occurs earlier, assessed up to 10 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (136)

Centre de Radiothérapie et d'Oncologie de Moyenne Garonne (CROMG); 🇫🇷 Agen, France

Hôpital Privé d'Aix en Provence; 🇫🇷 Aix-en-provence, France

Centre Hospitalier Général d'Aix-en-Provence; 🇫🇷 Aix-en-Provence, France

CHU Amiens; 🇫🇷 Amiens, France

Clinique Victor PAUCHET; 🇫🇷 Amiens, France

Institut de Cancérologie de l'Ouest - ICO; 🇫🇷 Saint-Herblain, France

Hôpital Privé d'Antony - Ramsay Santé; 🇫🇷 Antony, France

CH Arras; 🇫🇷 Arras, France

CH Auxerre; 🇫🇷 Auxerre, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

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