Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms

Completed

• Conditions: Neurofibromatosis 1; Diagnoses Disease; Post Traumatic Stress Disorder

• Registration Number: NCT03298438
• Lead Sponsor: University Hospital, Brest

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-29
• Last Update Submitted: 2017-09-29
• Study First Posted: 2017-10-02
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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

Exclusion Criteria

• Patients aged of 18 years old or lower
• Refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form	Day 1 after diagnosis of neurofibromatosis	Questionnaire Impact of Event Scale

Secondary Outcome Measures

Name	Time	Method
Study methods of annoucement and feeling of patients with a questionnaire	Day 1 after diagnosis of neurofibromatosis	Questionnaires about: methods of announcement (who? when? how?)
Genetical analyze	Day 1 after diagnosis of neurofibromatosis	Genetical analyze
Psychological or psychiatrical impact	Day 1 after diagnosis of neurofibromatosis	Psychological or psychiatrical impact
Information about NF1	Day 1 after diagnosis of neurofibromatosis	Questions about look for information about disease

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France