Neurofibromatosis Type 1NCT02505412
Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients
An observational study of Neurofibromatosis Type 1, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed? Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis Type 1
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2018
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Consecutive asymptomatic NF1 patients, aged 0-17y and 11 month, who will visit the investigators' Neurofibromatosis tertiary outpatients clinics
Who may be able to join
- asymptomatic NF1 patients
- aged 0-17y and 11 months
Who cannot join
- clinical heart failure,
- history of cardiovascular disease
- chronic renal insufficiency
About this study
Official title: Prevalence of Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients: is Cardiac Screening Needed?
Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?
- Conditions
- Neurofibromatosis Type 1
- Medical subject headings
- Neurofibromatosis 1
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial deformation indices as measured in percentage (change of original length)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505412
- Sponsor's protocol ID
- TLV-0212-15
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients: is Cardiac Screening Needed?
- ClinicalTrials.gov ID
- NCT02505412
- Acronym / sponsor ID
- TLV-0212-15
- Conditions
- Neurofibromatosis Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jul 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.
Subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Consecutive asymptomatic NF1 patients, aged 0-17y and 11 month, who will visit the investigators' Neurofibromatosis tertiary outpatients clinics
Key inclusion criteria (2 listed)
- asymptomatic NF1 patients
- aged 0-17y and 11 months
Key exclusion criteria (3 listed)
- clinical heart failure,
- history of cardiovascular disease
- chronic renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
myocardial deformation indices as measured in percentage (change of original length)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis Type 1, run by Tel-Aviv Sourasky Medical Center.
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 3 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
myocardial deformation indices as measured in percentage (change of original length) (time frame: up to 2 years). 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 22 Jul 2015.