Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54506, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 18 years
Patient with stage III to IV non-treated high grade ovarian cancer or recurrent high grade ovarian cancer
Adequate haemoglobin rate ≥ 9 g/dL
Patient who can benefit from an additional blood sample of 20ml. The total volume of each sample meets with the indications of the Order in force establishing the list of researches mentioned in 2 ° of Article L. 1121-1 of the Public Health Code.
Availability of tumor samples from biopsy or surgery
Patient affiliated to a social security scheme
Ability to provide written informed consent

Exclusion criteria

Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
Contraindication to a blood sample of 20 mL
Pregnant or breast-feeding women
Ongoing treatment for the newly diagnosed cancer or the recurrence
Patient pre-treated with poly-ADP-ribose-polymérase-1 (PARP) Inhibitors
Patient under guardianship or curatorship or deprived of liberty.

Treatment and study plan

HRD and BRCA mutations

Diagnostic Test

Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy

Primary outcomes

Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)

Time frame: 1 day (samples will be analyzed in batch at the end of inclusions)

Number of patients with detected punctual somatic mutations (SNVs and indels of BRCA1/2 and genes involved in HRD) concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma

Secondary outcomes

Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV)

Time frame: 1 day (samples will be analyzed in batch at the end of inclusions)

Number of patients with detected genomic alterations (large rearrangements, LOH and CNV of BRCA1/2 and genes involved in HRD) concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: BOVARY Pilot

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Mar 19, 2019
Registry last updated: Mar 31, 2022

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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Completed