Clinical trial · Observational
FARD (RaDiCo Cohort) (RaDiCo-FARD)
National Cohort for Evaluation of the Burden of Rare Skin Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Albinism | — | UNRESOLVED | — |
| Ectodermal Dysplasia | — | UNRESOLVED | — |
| Ichthyosis | — | UNRESOLVED | — |
| Incontinentia Pigmenti | — | UNRESOLVED | — |
| Inherited Epidermolysis Bullosa | — | UNRESOLVED | — |
| Mucous Membrane Pemphigoid | — | UNRESOLVED | — |
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
| Palmoplantar Keratoderma | — | UNRESOLVED | — |
| Pemphigus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Individual burden score for each selected rare disease
- timeFrame
- Through study completion, an average of 5 years
- description
- 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.
Secondary outcomes (7)
- measure
- Description of calculated scores based on widely used survey completed by patients
- timeFrame
- Through study completion, an average of 5 years
- measure
- Description of calculated scores based on widely used survey completed by parents
- timeFrame
- Through study completion, an average of 5 years
- measure
- Description of variations of quality-of-life scores.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available