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

Ovarian Cancer Clinical Trial

— BOVARY Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881683
• Other study ID #: 2018-A03113-52
• Status: Completed
• Phase: N/A
• Start date: February 21, 2020
• Est. completion date: February 19, 2021

Study information

• Verified date: March 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• HRD and BRCA mutations
Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)	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	1 day (samples will be analyzed in batch at the end of inclusions)
Secondary	Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV)	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	1 day (samples will be analyzed in batch at the end of inclusions)