Neurofibromatosis 1NF1NCT03298438
Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms
An observational study of Neurofibromatosis 1 and Diagnoses Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis 1, Diagnoses Disease, Post Traumatic Stress Disorder
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2016to 31 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients or parent of a children followed for a neurofibromatosis type 1 in de novo form
Who may be able to join
- Patient aged 18 or more, or parent of a children
- Patient with a neurofibromatosis type 1 or parent of a children with a neurofibromatosis 1 in de novo form
- Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the University Hospital of Brest, since april 2013
- Agree to participate
Who cannot join
- Patients aged of 18 years old or lower
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.
- Medical subject headings
- Neurofibromatosis 1, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form
Questionnaire Impact of Event Scale
Measured: Day 1 after diagnosis of neurofibromatosis
Secondary outcomes (4)
Study methods of annoucement and feeling of patients with a questionnaire
Questionnaires about: methods of announcement (who? when? how?)
Measured: Day 1 after diagnosis of neurofibromatosis
Genetical analyze
Genetical analyze
Measured: Day 1 after diagnosis of neurofibromatosis
Psychological or psychiatrical impact
Psychological or psychiatrical impact
Measured: Day 1 after diagnosis of neurofibromatosis
Information about NF1
Questions about look for information about disease
Measured: Day 1 after diagnosis of neurofibromatosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start15 Jul 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298438
- Sponsor's protocol ID
- NF1
- Acronym
- NF1
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 2 Oct 2017
- 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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms
- ClinicalTrials.gov ID
- NCT03298438
- Acronym / sponsor ID
- NF1 / NF1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Oct 2017 (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.
Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients or parent of a children followed for a neurofibromatosis type 1 in de novo form
Key inclusion criteria (4 listed)
- Patient aged 18 or more, or parent of a children
- Patient with a neurofibromatosis type 1 or parent of a children with a neurofibromatosis 1 in de novo form
- Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the University Hospital of Brest, since april 2013
- Agree to participate
Key exclusion criteria (2 listed)
- Patients aged of 18 years old or lower
- Refusal to participate
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
Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form
Time frame: Day 1 after diagnosis of neurofibromatosis
Questionnaire Impact of Event Scale
4 secondary outcomes
Study methods of annoucement and feeling of patients with a questionnaire
Time frame: Day 1 after diagnosis of neurofibromatosis
Genetical analyze
Time frame: Day 1 after diagnosis of neurofibromatosis
Psychological or psychiatrical impact
Time frame: Day 1 after diagnosis of neurofibromatosis
Information about NF1
Time frame: Day 1 after diagnosis of neurofibromatosis
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 2 Oct 2017.
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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.
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 1 and Diagnoses Disease, run by University Hospital, Brest 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 4 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: finished, as of the sponsor's last update on 2 Oct 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 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?
Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form (time frame: Day 1 after diagnosis of neurofibromatosis). 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 2 Oct 2017.