Study About Annoucement of the Diagnosis of Neurofibromat... | NCT03298438

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

NCT03298438

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Oct 2, 2017Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Neurofibromatosis 1
Diagnoses Disease
Post Traumatic Stress Disorder

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Sep 11, 2017

First Submission Date that Met QC Criteria

Sep 29, 2017

First Posted Date

Oct 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Genetical analyze

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D009456	Neurofibromatosis 1
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D017253	Neurofibromatoses
D009455	Neurofibroma
D018317	Nerve Sheath Neoplasms
D009380	Neoplasms, Nerve Tissue

Browse Leaves

Not provided

Browse Branches

Not provided