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Completed

NCT Number: NCT04027868

Genomic BRCA and Extensive ovArian Cancer Testing

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

Secondary outcomes

  1. Correlation between age and the detected tumor genetic abnormalities

    Time frame: Baseline

  2. Correlation between histology status and the detected tumor genetic abnormalities

    Time frame: Baseline

  3. Correlation between FIGO stage and the detected tumor genetic abnormalities

    Time frame: Baseline

  4. Correlation between surgery resection status and the detected tumor genetic abnormalities

    Time frame: Up to 10 years

  5. Correlation between treatment response and the detected tumor genetic abnormalities

    Time frame: Up to 10 years

  6. Correlation between Overall survival (OS) and the detected tumor genetic abnormalities

    Time frame: From baseline to death, assessed up to 10 years

Other outcomes

  1. Percentage of patients with both germinal and tumoral BRCA tests

    Time frame: Up to 10 years

  2. Percentage of patients with a first germinal BRCA test, a first tumoral BRCA test, or simultaneous germinal and tumoral tests

    Time frame: Up to 10 years

  3. Percentage of patients with and exploitable tumoral block for exploratory transversal researches

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: GREAT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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