FARD (RaDiCo Cohort) (RaDiCo-FARD)
FARD
National Cohort for Evaluation of the Burden of Rare Skin Diseases
1 other identifier
observational
900
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 7, 2027
February 12, 2026
February 1, 2026
9 years
June 26, 2023
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Individual burden score for each selected rare disease
Before 16 years old, we will focus on the burden of families. After 16 years old, the patient's parent will continue to answer to the family Burden questionnaire and the patient will start to answer to the adult's Burden questionnaire.
Through study completion, an average of 5 years
Secondary Outcomes (7)
Description of calculated scores based on widely used survey completed by patients
Through study completion, an average of 5 years
Description of calculated scores based on widely used survey completed by parents
Through study completion, an average of 5 years
Description of variations of quality-of-life scores.
Through study completion, an average of 5 years
Validation of the clinical severity score for disease which have none at the beginning of the study and description of clinical severity score.
Through study completion, an average of 5 years
Descriptive analysis of the socio-economic Burden.
Through study completion, an average of 5 years
- +2 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Hôpital Avicenne
Bobigny, France
Hôpital des Enfants - Groupe Hospitalier Pellegrin
Bordeaux, France
Hôpital des Enfants - Groupe Hospitalier Pellegrin
Bordeaux, France
Hôpital Henri-Mondor
Créteil, France
Hôpital François Mitterrand
Dijon, France
Hôpital Dupuytren
Limoges, France
Hôpital de la Timone
Marseille, France
Hôpital Saint-Eloi
Montpellier, France
Hôpital l'Archet
Nice, France
Hôpital Necker-Enfants Malades
Paris, France
Hôpital Saint-Louis
Paris, France
Hôpital Robert-Debré
Reims, France
Hôpital Charles Nicolle
Rouen, France
Hôpital Larrey
Toulouse, France
Hôpital Trousseau
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine BODEMER
INSERM UMR 1163
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 20, 2023
Study Start
March 7, 2018
Primary Completion (Estimated)
March 7, 2027
Study Completion (Estimated)
March 7, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02