Establishment of a Patient Library in Patients With Pruritus Sine Materia (PRURITHEQUE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pruritus; Chronic Pruritus; Itch
• Intervention / Treatment: Other: Blood samples; Other: skin swab sample; Other: skin biopsy sample; Other: Questionnaires

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 175

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Service de dermatologie, CHRU BREST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with pruritus sine materia

Description

Inclusion Criteria:

• Diagnosis of pruritus sine materia
• Collection of consent
• Adult

Exclusion Criteria:

- Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patient library; Patient with pruritus sine materia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Brest Questionnaire	The Brest questionnaire is a descriptive tool. No score is calculated.	5 years
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): February 1, 2033
• Study Completion (Anticipated): February 1, 2033

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: 29BRC17.0168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No