Official Title
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Brief Title
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Protocol ID
NCT03881683
Lead Sponsor
Institut de Cancérologie de Lorraine
Brief 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
Study Period
-
Enrollment Count
24 participants
Eligibility Criteria
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.
Filters
Ovarian Cancer
NA
COMPLETED
ADULT
OLDER_ADULT