Pathogenic Study of Adult Immune Enteropathies

NCT ID: NCT04280510

Last Updated: 2025-09-18

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-27

Study Completion Date

2033-02-27

Brief Summary

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The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.

Detailed Description

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Conditions

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Celiac Disease Autoimmune Enteropathy Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active coeliac patients

Patients with active coeliac disease

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Treated coeliac patients

Patients with coeliac disease on gluten free diet

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Sprue type I

Patients with refractory coeliac disease of type I

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Sprue type II

Patients with refractory coeliac disease of type II

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Intestinal Lymphoproliferations

Patients with intestinal lymphoproliferations

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Non coeliac enteropathies

Patients with non coeliac immune-mediated enteropathy

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Patients without neoplastic or inflammatory intestinal disease

Patients without neoplastic or inflammatory intestinal disease

Blood sample collection; gastrointestinal biopsy

Intervention Type GENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Interventions

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Blood sample collection; gastrointestinal biopsy

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 18 years or over
* affiliated to social insurance
* signed informed consent

Exclusion Criteria

* pregnancy
* under guardianship
* not able to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imagine Institute

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georgia MALAMUT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP, Université de Paris (Université Paris Descartes)

Locations

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Hôpital Henri Mondor

Créteil, , France

Site Status NOT_YET_RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status NOT_YET_RECRUITING

Hôpital Saint Louis

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Cochin

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Georgia MALAMUT, MD, PhD

Role: CONTACT

33 1 58 41 41 76

Anaïs LEVESCOT, MD, PhD

Role: CONTACT

33 1 42 75 42 77

Facility Contacts

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Iradj Sobhani, MD, PhD

Role: primary

Franck Carbonnel, MD, PhD

Role: primary

Matthieu ALLEZ, MD, PhD

Role: primary

Georgia Malamut, MD, PhD

Role: primary

Other Identifiers

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2019-A01594-53

Identifier Type: REGISTRY

Identifier Source: secondary_id

C19-07

Identifier Type: -

Identifier Source: org_study_id

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