BRCA1 Gene MutationNCT02474264
The Link Between BRCA Mutation and Endothelial Function
A study testing Endothelial function assessment, Cardiovascular biomarkers and Endothelial cells in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This study evaluates the effect of BRCA1\&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- Endothelial function assessment, Cardiovascular biomarkers and Endothelial cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2015to Nov 2018
- 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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
- Able and willing to sign an informed consent
Who cannot join
- History of, or current, malignancy
- History of:
- Myocardial infarction
- Ischemic or Hemorrhagic cerebrovascular conditions
- Arterial embolic and thrombotic events
- Ischemic heart disease
- Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
- Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Beilinson Hospital
Petah Tikva
David Margel, MD PhD, +972(0)39376553
David Margel, MD Phd
About this study
Official title: The Link Between BRCA Mutation and Endothelial Function - A Pilot Study
This study evaluates the effect of BRCA1\&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Being tested
- Endothelial function assessment, Cardiovascular biomarkers, Endothelial cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial function assessmentOther
reactive hyperemia index
Cardiovascular biomarkersOther
Cardiovascular biomarkers will be measure to test other aspects of endothelial and cardiac function: high-sensitivity troponin (hsTn) , C-reactive protein , D-dimer, N-terminal pro-brain natriuretic peptide (NT-proBNP)
Endothelial cellsOther
Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.
| Study group | Role | What they receive |
|---|---|---|
| male BRCA mutations carriers | Other | Endothelial function assessment and Cardiovascular biomarkers Receives: Other: Endothelial function assessment; Other: Cardiovascular biomarkers; Other: Endothelial cells |
| healthy males - control group | Other | Endothelial function assessment and Cardiovascular biomarkers Receives: Other: Endothelial function assessment; Other: Cardiovascular biomarkers; Other: Endothelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
reactive hyperemia index will be assessed using the Endo-PAT2000
will be assessed using the Endo-PAT2000
Measured: at baseline
Secondary outcomes (6)
The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured
high sensitivity troponin (hsTn)
Measured: at baseline
The level of C-reactive protein - a cardiovascular risk biomarker will be measured
C-reactive protein
Measured: at baseline
The level of D-dimer - a cardiovascular risk biomarker will be measured
D-dimer
Measured: at baseline
The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Measured: at baseline
Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.
Endothelial Progenitor Cells (EPC)
Measured: at baseline
Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.
Circulating Endothelial Cells (CEC)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 Gene MutationStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD, PhD, Principal investigator, Rabn Medical Center, Beilinson Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474264
- Sponsor's protocol ID
- 0594-14-RMC
- Status last verified
- Oct 2016
- First submitted
- 23 Feb 2015
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between BRCA Mutation and Endothelial Function - A Pilot Study
- ClinicalTrials.gov ID
- NCT02474264
- Acronym / sponsor ID
- 0594-14-RMC
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 17 Jun 2015 (estimated)
- 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.
This study evaluates the effect of BRCA1\&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male BRCA mutations carriers | Other | Other: Endothelial function assessment, Other: Cardiovascular biomarkers, Other: Endothelial cellsEndothelial function assessment and Cardiovascular biomarkers |
| healthy males - control group | Other | Other: Endothelial function assessment, Other: Cardiovascular biomarkers, Other: Endothelial cellsEndothelial function assessment and Cardiovascular biomarkers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
- Able and willing to sign an informed consent
Key exclusion criteria (8 listed)
- History of, or current, malignancy
- History of:
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 |
|---|---|---|
| Endothelial function assessmentreactive hyperemia index | Other | healthy males - control group, male BRCA mutations carriers |
| Cardiovascular biomarkersCardiovascular biomarkers will be measure to test other aspects of endothelial and cardiac function: high-sensitivity troponin (hsTn) , C-reactive protein , D-dimer, N-terminal pro-brain natriuretic peptide (NT-proBNP) | Other | healthy males - control group, male BRCA mutations carriers |
| Endothelial cellsEndothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury. | Other | healthy males - control group, male BRCA mutations carriers |
Primary outcome
reactive hyperemia index will be assessed using the Endo-PAT2000
Time frame: at baseline
will be assessed using the Endo-PAT2000
6 secondary outcomes
The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured
Time frame: at baseline
The level of C-reactive protein - a cardiovascular risk biomarker will be measured
Time frame: at baseline
The level of D-dimer - a cardiovascular risk biomarker will be measured
Time frame: at baseline
The level of N-terminal pro-brain natriuretic peptide (NT-proBNP) - a cardiovascular risk biomarker will be measured
Time frame: at baseline
Endothelial Progenitor Cells profile (EPC) - will be characterized to evaluate endothelial injury.
Time frame: at baseline
Circulating Endothelial Cells profile (CEC) - will be characterized to evaluate endothelial injury.
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
David Margel, MD, PhD principal investigator
Rabn Medical Center, Beilinson Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothelial function assessment, Cardiovascular biomarkers and Endothelial cells in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Rabin Medical Center at 1 site in Israel.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jul 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Margel, MD, PhD (+972(0)39376553, sdmargel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reactive hyperemia index will be assessed using the Endo-PAT2000 (time frame: at baseline). 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 18 Jul 2017.