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NCT03298438 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

— NF1  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03298438
Other study ID # NF1
Secondary ID
Status Completed
Phase N/A
First received September 11, 2017
Last updated September 29, 2017
Start date July 15, 2016
Est. completion date December 31, 2016

Study information
Verified date September 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form Questionnaire Impact of Event Scale Day 1 after diagnosis of neurofibromatosis
Secondary Study methods of annoucement and feeling of patients with a questionnaire Questionnaires about: methods of announcement (who? when? how?) Day 1 after diagnosis of neurofibromatosis
Secondary Genetical analyze Genetical analyze Day 1 after diagnosis of neurofibromatosis
Secondary Psychological or psychiatrical impact Psychological or psychiatrical impact Day 1 after diagnosis of neurofibromatosis
Secondary Information about NF1 Questions about look for information about disease Day 1 after diagnosis of neurofibromatosis
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