Deployment o the Multidisciplinary Prospective Cohort Imminent

NCT ID: NCT04334031

Last Updated: 2022-05-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

2200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2031-07-31

Brief Summary

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Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.

Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment.

These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

Detailed Description

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Conditions

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Chronic Inflammatory Disease Angioedema Severe Asthma Lupus Atopic Dermatitis Psoriatic Arthritis Multiple Sclerosis Systemic Sclerosis Behçet Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IMMINeNT cohort

Group Type EXPERIMENTAL

Biobanking with genetic analysis

Intervention Type GENETIC

Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.

SF-12 questionnaire

Intervention Type OTHER

Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Interventions

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Biobanking with genetic analysis

Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.

Intervention Type GENETIC

SF-12 questionnaire

Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)
* Social insured
* Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.

Exclusion Criteria

* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.
* Pregnant or breastfeeding woman
* Persons deprived of liberty
* Protected minors or adults
* Persons who have refused or are incapable of giving informed consent
* Persons in Emergency Situations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FHU IMMINeNT

UNKNOWN

Sponsor Role collaborator

FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs

UNKNOWN

Sponsor Role collaborator

Fond de dotation de la Société Française de Dermatologie (SFD)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Launay, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David Launay, MD,PhD

Role: CONTACT

03 20 44 42 95 ext. +33

Facility Contacts

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Role: primary

0320445962

Other Identifiers

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2019-A01309-48

Identifier Type: OTHER

Identifier Source: secondary_id

2018_82

Identifier Type: -

Identifier Source: org_study_id

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