Establishment of a Patient Library in Patients With Pruritus Sine Materia

NCT ID: NCT05678309

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2033-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pruritus Chronic Pruritus Itch

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patient library

Patient with pruritus sine materia

Blood samples

Intervention Type OTHER

At inclusion :

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

skin swab sample

Intervention Type OTHER

At inclusion a skin swab sample will be collected

skin biopsy sample

Intervention Type OTHER

At inclusion a skin biopsy sample will be collected

Questionnaires

Intervention Type 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

Interventions

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Blood samples

At inclusion :

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

Intervention Type OTHER

skin swab sample

At inclusion a skin swab sample will be collected

Intervention Type OTHER

skin biopsy sample

At inclusion a skin biopsy sample will be collected

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de dermatologie, CHRU BREST

Brest, , France

Site Status

Countries

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France

Central Contacts

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Laurent MISERY

Role: CONTACT

02 98 22 33 15

Emilie BRENAUT

Role: CONTACT

Other Identifiers

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29BRC17.0168

Identifier Type: -

Identifier Source: org_study_id

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