Ovarian CancerBOVARY PilotNCT03881683
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
A study testing HRD and BRCA mutations in people with Ovarian Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- HRD and BRCA mutations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2020to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Ovarian Cancer
- Being tested
- HRD and BRCA mutations
- Keywords
- BRCA 1/2 genes, Circulating Tumor DNA/blood*, somatic tumor mutations, HRD genes
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRD and BRCA mutationsDiagnostic test
Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy
| Study group | Role | What they receive |
|---|---|---|
| HRD and BRCA mutations | Experimental | Not described Receives: Diagnostic Test: HRD and BRCA mutations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (samples will be analyzed in batch at the end of inclusions)
Secondary outcomes (1)
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
Measured: 1 day (samples will be analyzed in batch at the end of inclusions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start21 Feb 2020
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAVOILLE CELINE, MD, Principal investigator, Institut de Cancérologie de LorraineHARLE ALEXANDRE, PhD pharmaD, Study chair, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881683
- Sponsor's protocol ID
- 2018-A03113-52
- Acronym
- BOVARY Pilot
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03881683
- Acronym / sponsor ID
- BOVARY Pilot / 2018-A03113-52
- Conditions
- Ovarian Cancer
- Keywords
- BRCA 1/2 genes, Circulating Tumor DNA/blood*, somatic tumor mutations, HRD genes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRD and BRCA mutations | Experimental | Diagnostic Test: HRD and BRCA mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRD and BRCA mutationsCompare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy | Diagnostic test | HRD and BRCA mutations |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GAVOILLE CELINE, MD principal investigator
Institut de Cancérologie de Lorraine
HARLE ALEXANDRE, PhD pharmaD study chair
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRD and BRCA mutations in people with Ovarian Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.