Trial Title:
FARD (RaDiCo Cohort) (RaDiCo-FARD)
NCT ID:
NCT05954416
Condition:
Inherited Epidermolysis Bullosa
Ichthyosis
Ectodermal Dysplasia
Incontinentia Pigmenti
Neurofibromatosis Type 1
Albinism
Pemphigus
Mucous Membrane Pemphigoid
Palmoplantar Keratoderma
Conditions: Official terms:
Neurofibromatoses
Neurofibromatosis 1
Albinism
Pemphigoid, Benign Mucous Membrane
Epidermolysis Bullosa
Ichthyosis
Ectodermal Dysplasia
Keratoderma, Palmoplantar
Incontinentia Pigmenti
Pemphigoid, Bullous
Pemphigus
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Summary:
The goal of this observational study is to conduct a prospective assessment of the
individual Burden of 9 rare skin diseases to assess disability in the broadest sense of
the term (psychological, social, economic and physical) for patients and/or families.
Two types of indicators will be used to reach this objective :
1. an individual burden score calculated based on a burden questionnaire created
specifically, approved and designed to understand the tendency to changes in care
and lifestyles. The burden questionnaire should be used by patients and/or their
family themselves in self-assessment.
2. a descriptive analysis of all resources (medical and non-medical) used by the family
unit to manage the disease.
Criteria for eligibility:
Study pop:
This study concerns patients affected by one the 9 following rare skin diseases:
Inherited epidermolysis bullosa, ichthyosis, ectodermal dysplasia, Incontinentia
Pigmenti, neurofibromatosis type 1, albinism, pemphigus, mucous membrane pemphigoid, and
palmoplantar keratoderma recruited and followed in a reference/competence centre of the
healthcare network of rare dermatologic diseases, FIMARAD.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria :
- adults or children with a confirmed diagnosis of one of the 9 following rare skin
disease: Inherited epidermolysis bullosa, Ichthyosis, Ectodermal dysplasia,
Incontinetia Pigmenti, Neurofibromatosis type 1, Albinism, Pemphigus, Mucous
membrane pemphigoid or Palmoplantar keratoderma.
- prevalent or incident and followed in one the reference/competence centers of the
FIMARAD healthcare network,
- able to understand a survey (for child, survey should be understood by parents),
- having given their signed consent to participate to the cohort RaDiCo-FARD (parents'
consent for child).
Non-inclusion criteria :
- Patients, for whom regular care follow-up is not feasible with the FIMARAD
healthcare network sites,
- Unconfirmed diagnosis (according to criteria for each disease),
- Patients (and/or parents) not able to understand a survey
- Patients (and/or parents) not having given their signed consent to participate to
the study
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Avicenne
Address:
City:
Bobigny
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Catherine PROST
Facility:
Name:
Hôpital des Enfants - Groupe Hospitalier Pellegrin
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christine LEAUTE-LABREZE
Facility:
Name:
Hôpital des Enfants - Groupe Hospitalier Pellegrin
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie-Sylvie DOUTRE
Facility:
Name:
Hôpital Henri-Mondor
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre WOLKENSTEIN
Facility:
Name:
Hôpital François Mitterrand
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre VABRE
Facility:
Name:
Hôpital Dupuytren
Address:
City:
Limoges
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Christophe BEDANE
Facility:
Name:
Hôpital de la Timone
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie-Aleth RICHARD
Facility:
Name:
Hôpital Saint-Eloi
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Didier BESSIS
Facility:
Name:
Hôpital l'Archet
Address:
City:
Nice
Country:
France
Status:
Recruiting
Contact:
Last name:
Christine CHIAVERINI
Facility:
Name:
Hôpital Necker-Enfants Malades
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Christine BODEMER
Facility:
Name:
Hôpital Saint-Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuelle BOURRAT
Facility:
Name:
Hôpital Robert-Debré
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Philippe BERNARD
Facility:
Name:
Hôpital Charles Nicolle
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Contact:
Last name:
Pascal JOLY
Facility:
Name:
Hôpital Larrey
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Juliette MAZEREEUW-HAUTIER
Facility:
Name:
Hôpital Trousseau
Address:
City:
Tours
Country:
France
Status:
Recruiting
Contact:
Last name:
Annabel MARUANI
Start date:
March 7, 2018
Completion date:
March 7, 2027
Lead sponsor:
Agency:
Institut National de la Santé Et de la Recherche Médicale, France
Agency class:
Other
Source:
Institut National de la Santé Et de la Recherche Médicale, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05954416
