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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05678309
Other study ID # 29BRC17.0168
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date February 1, 2033

Study information

Verified date March 2023
Source University Hospital, Brest
Contact Laurent MISERY
Phone 02 98 22 33 15
Email laurent.misery@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 175
Est. completion date February 1, 2033
Est. primary completion date February 1, 2033
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Diagnosis of pruritus sine materia - Collection of consent - Adult Exclusion Criteria: - Refusal to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood samples
At inclusion : 52.5 ml of blood : 24 ml plasma 20 ml serum 6 ml DNA 2.5 ml RNA
skin swab sample
At inclusion a skin swab sample will be collected
skin biopsy sample
At inclusion a skin biopsy sample will be collected
Questionnaires
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

Locations

Country Name City State
France Service de dermatologie, CHRU BREST Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical description of the pruritus Chronology 5 years
Primary Clinical description of the pruritus Intensity 5 years
Primary Clinical description of the pruritus Location 5 years
Primary Clinical description of the pruritus Aggravating and ameliorating factors 5 years
Primary Clinical description of the pruritus Evolution 5 years
Primary Clinical description of the pruritus Scratching 5 years
Primary Clinical description of the pruritus Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching 5 years
Primary 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
Primary 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
Primary 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
Primary Brest Questionnaire The Brest questionnaire is a descriptive tool. No score is calculated. 5 years
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