Neurofibromatosis Type 1NCT01626846
How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and Self-Esteem
An observational study of Neurofibromatosis Type 1, run by John Jay High School at 1 site in United States.
Trial summary
The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis Type 1
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Teenagers aged 14-17 years with NF1
Who may be able to join
- Clinical diagnosis of Neurofibromatosis Type 1
Who cannot join
- Neurofibromatosis Type 2
- Schwannomatosis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
John Jay High School
Cross River, New York, 10518
Chris Ramsay, christopher.ramsay@klschools.org
About this study
Official title: Cognitive Impairments, Self-Esteem & Academic Performance in Teenagers With Neurofibromatosis Type 1
The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1.
- Conditions
- Neurofibromatosis Type 1
- Keywords
- Neurofibromatosis
- Medical subject headings
- Neurofibromatosis 1, Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NF1 teenagers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of effect on self-esteem evidenced by self-esteem scores
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Study completionSep 2012 (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.
- 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
- John Jay High School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eileen Karlik, PhD, Study director, Westchester Community College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626846
- Sponsor's protocol ID
- NF Survey 2012
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairments, Self-Esteem & Academic Performance in Teenagers With Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT01626846
- Acronym / sponsor ID
- NF Survey 2012
- Conditions
- Neurofibromatosis Type 1
- Keywords
- Neurofibromatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- John Jay High SchoolUniversity, hospital or other
- Study start
- Jun 2012
- Study completion
- Sep 2012 (estimated)
- First posted
- 25 Jun 2012 (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.
The study will seek to determine whether there is a corresponding deficit in school performance for teenagers with NF1. Secondly, the study seeks to explore the issue of self-esteem in teenagers with NF1.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NF1 teenagers | – | – |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Teenagers aged 14-17 years with NF1
Key inclusion criteria (1 listed)
- Clinical diagnosis of Neurofibromatosis Type 1
Key exclusion criteria (2 listed)
- Neurofibromatosis Type 2
- Schwannomatosis
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
Evidence of effect on self-esteem evidenced by self-esteem scores
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
Related trials for Neurofibromatosis Type 1
Active, not recruitingObservational study
Natural History Study of Cutaneous Neurofibromas in People With NF1
Neurofibromatosis Type 1, Neurofibromatosis 1
RecruitingObservational study
The NF Registry Sponsored by the Children's Tumor Foundation
Neurofibromatosis 1, Neurofibromatosis 2
RecruitingObservational study
Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
Neurofibromatosis Type 1 (NF1)
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Not yet recruitingPhase 1
A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
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.
Eileen Karlik, PhD study director
Westchester Community College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis Type 1, run by John Jay High School at 1 site in United States.
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 1 inclusion and 2 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 25 Jun 2012. 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 United States. 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 Chris Ramsay (914-355-8010, christopher.ramsay@klschools.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of effect on self-esteem evidenced by self-esteem scores (time frame: 4 months). 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 25 Jun 2012.