Establishment of a Patient Library in Patients With Pruritus Sine Materia

Pruritus Clinical Trial

— PRURITHEQUE  

Official title:

Establishment of a Patient Library in Patients With Pruritus Sine Materia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05678309
• Other study ID #: 29BRC17.0168
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Pruritus
• Itch
• Pruritus

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