Establishment of a Patient Library in Patients With Pruritus Sine Materia

Study Overview
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Brief Summary
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Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

Detailed Description
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At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient. At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.

Official Title
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Establishment of a Patient Library in Patients With Pruritus Sine Materia

Conditions
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Pruritus, Chronic Pruritus, Itch

Intervention / Treatment
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* Other: Blood samples
* Other: skin swab sample
* Other: skin biopsy sample
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pruritus sine materia Collection of consent Adult Exclusion Criteria: - Refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient library<br>Patient with pruritus sine materia | Other: Blood samples<br>* At inclusion : 52.5 ml of blood : 24 ml plasma 20 ml serum 6 ml DNA 2.5 ml RNA<br>Other: skin swab sample<br>* At inclusion a skin swab sample will be collected<br>Other: skin biopsy sample<br>* At inclusion a skin biopsy sample will be collected<br>Other: Questionnaires<br>* At inclusion, at 6 months and every year, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, Dermatology Life Quality Index, Itchy Quality of Life and Hospital Anxiety and Depression Scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical description of the pruritus | Chronology | 5 years | 
| Clinical description of the pruritus | Intensity | 5 years | 
| Clinical description of the pruritus | Location | 5 years | 
| Clinical description of the pruritus | Aggravating and ameliorating factors | 5 years | 
| Clinical description of the pruritus | Evolution | 5 years | 
| Clinical description of the pruritus | Scratching | 5 years | 
| Clinical description of the pruritus | Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching | 5 years | 
| 5-D itch scale questionnaire | The scores for each of the five domains (duration, degree, direction, disability, ditribution) are calculated separately and then added together to obtain a total 5-D score. The 5-D score can range from 5 (no pruritus) to 25 (most severe pruritus). Scores with a single item (duration, degree, direction) are equal to the value indicated by the answer choice (from 1 to 5). The impact of pruritus (disability) includes four items that assess the impact of itching on daily activities: sleep, leisure activities, social activities, domestic activities, work/study. The score for impact is reached by taking the highest score on any of the four items. For location (distribution), the number of body parts affected is collected (potential sum of 0 to 16) and the sum is classified into 5 scores: sum of 0 to 2 = score of 1 sum of 3 to 5 = score of 2 sum of 6 to 10 = score of 3 sum of 11 to 13 = score of 4 sum of 14 to 16 = score of 5 | 5 years | 
| Dermatology Life Quality Index questionnaire (DLQI) | DLQI = Dermatology Life Quality Index is a ten-item questionnaire. The score ranges from 0 to 30. Each question is rated from 0 to 3. The higher the score, the worse the health status. Interpretation of DLQI: DLQI scores 0-1: no effect on patient's life DLQI scores 2-5: small effect on patient's life DLQI scores 6-10: moderate effect on patient's life DLQI scores 11-20: very large effect on patient's life DLQI scores 21-30: extremely large effect on patient's life | 5 years | 
| Hospital anxiety and depression questionnaire (HAD) | The HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21). To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D) 7 or less: no symptomatology 8 to 10: doubtful symptomatology 11 and more: definite symptomatology. | 5 years | 
| Brest Questionnaire | The Brest questionnaire is a descriptive tool. No score is calculated. | 5 years |