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Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer (BOVARY Pilot)

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ClinicalTrials.gov Identifier: NCT03881683
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Official Title  ICMJE Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Diagnostic Test: HRD and BRCA mutations
Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy
Study Arms  ICMJE Experimental: HRD and BRCA mutations
Intervention: Diagnostic Test: HRD and BRCA mutations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MERLIN JEAN LOUIS, PharmD PhD 00 33 3 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: HUIN SCHOHN CECILE, PhD 00 33 3 83 59 86 07 c.huinschohn@nancy.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881683
Other Study ID Numbers  ICMJE 2018-A03113-52
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut de Cancérologie de Lorraine
Study Sponsor  ICMJE Institut de Cancérologie de Lorraine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: GAVOILLE CELINE, MD Institut de Cancérologie de Lorraine
Study Chair: HARLE ALEXANDRE, PhD pharmaD Institut de Cancérologie de Lorraine
PRS Account Institut de Cancérologie de Lorraine
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP