PRURITHEQUE: Establishment of a Patient Library in Patients With Pruritus Sine Materia.

Sponsor

University Hospital, Brest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05678309

Collaborator

(none)

175

Enrollment

Location

120

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus Chronic Pruritus Itch	Other: Blood samples Other: skin swab sample Other: skin biopsy sample Other: fecal 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

175 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Establishment of a Patient Library in Patients With Pruritus Sine Materia.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2033

Anticipated Study Completion Date :

Feb 1, 2033

Arms and Interventions

Arm	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: fecal sample At inclusion a fecal sample will be collected Other: Questionnaires At inclusion and every years, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, DLQI, ItchyQol and HAD

Arm

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: fecal sample

At inclusion a fecal sample will be collected

Other: Questionnaires

At inclusion and every years, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, DLQI, ItchyQol and HAD

Outcome Measures

Primary Outcome Measures

Clinical description of the prurit [5 years]
Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching
5-D itch scale questionnaire [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
DLQI questionnaire [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
HAD questionnaire [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.
Brest Questionnaire [5 years]
The Brest questionnaire is a descriptive tool. No score is calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of pruritus sine materia
Collection of consent
Adult

Exclusion Criteria:

Refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de dermatologie, CHRU BREST	Brest		France	29200

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT05678309

Other Study ID Numbers:

29BRC17.0168

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pruritus

Study Results

No Results Posted as of Jan 10, 2023