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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 : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Diagnostic Test: HRD and BRCA mutations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881683


Contacts
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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

Locations
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France
Institut de Cancerologie de Lorraine Not yet recruiting
Vandœuvre-lès-Nancy, France, 54506
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   
Principal Investigator: GAVOILLE CELINE, MD         
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: GAVOILLE CELINE, MD Institut de Cancérologie de Lorraine
Study Chair: HARLE ALEXANDRE, PhD pharmaD Institut de Cancérologie de Lorraine

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT03881683     History of Changes
Other Study ID Numbers: 2018-A03113-52
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de Lorraine:
BRCA 1/2 genes
Circulating Tumor DNA/blood*
somatic tumor mutations
HRD genes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type