Establishment of a Patient Library in Patients With Pruritus Sine Materia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Dermatology Life Quality Index questionnaire (DLQI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pruritus sine materia
- •Collection of consent
排除标准
- •- Refusal to participate in the study
结局指标
主要结局
Dermatology Life Quality Index questionnaire (DLQI)
时间窗: 5 years
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
Hospital anxiety and depression questionnaire (HAD)
时间窗: 5 years
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-D itch scale questionnaire
时间窗: 5 years
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
Brest Questionnaire
时间窗: 5 years
The Brest questionnaire is a descriptive tool. No score is calculated.
Clinical description of the pruritus
时间窗: 5 years
Chronology
次要结局
未报告次要终点