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

NCT03298438 | Completed

• 1 other identifier: NF1
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis 1; Diagnoses Disease; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Study methods of annoucement and feeling of patients with a questionnaire

  Day 1 after diagnosis of neurofibromatosis

• Genetical analyze

  Day 1 after diagnosis of neurofibromatosis

• Psychological or psychiatrical impact

  Day 1 after diagnosis of neurofibromatosis

• Information about NF1

  Day 1 after diagnosis of neurofibromatosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients or parent of a children followed for a neurofibromatosis type 1 in de novo form

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: October 2, 2017
• Study Start: July 15, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

FR (1)