Establishment of a Patient Library in Patients With Pruritus Sine Materia

NCT05678309 | Not Yet Recruiting

• 1 other identifier: 29BRC17.0168
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pruritus; Chronic Pruritus; Itch

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

patient library

Patient with pruritus sine materia

Other: Blood samples; Other: skin swab sample; Other: skin biopsy sample; Other: Questionnaires

Interventions

Blood samples OTHER

At inclusion : * 52.5 ml of blood : * 24 ml plasma * 20 ml serum * 6 ml DNA * 2.5 ml RNA

patient library

skin swab sample OTHER

At inclusion a skin swab sample will be collected

patient library

skin biopsy sample OTHER

At inclusion a skin biopsy sample will be collected

patient library

Questionnaires OTHER

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

patient library

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with pruritus sine materia

You may qualify if:

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

You may not qualify if:

• \- Refusal to participate in the study

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Service de dermatologie, CHRU BREST

Brest, 29200, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

6 mL of blood will be collected at inclusion to extract the dna

MeSH Terms

Conditions

Pruritus

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Laurent MISERY

CONTACT

02 98 22 33 15; laurent.misery@chu-brest.fr

Emilie BRENAUT

CONTACT

emilie.brenaut@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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

Locations

FR (1)