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Pathogenic Study of Adult Immune Enteropathies (ENTEROPAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280510
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Imagine Institute
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
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.

Condition or disease Intervention/treatment
Celiac Disease Autoimmune Enteropathy Inflammatory Bowel Diseases Genetic: Blood sample collection; gastrointestinal biopsy

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathogenic Study of Adult Immune Enteropathies
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : February 27, 2028
Estimated Study Completion Date : February 27, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Group/Cohort Intervention/treatment
Active coeliac patients
Patients with active coeliac disease
Genetic: Blood sample collection; gastrointestinal biopsy
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
Genetic: Blood sample collection; gastrointestinal biopsy
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
Genetic: Blood sample collection; gastrointestinal biopsy
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
Genetic: Blood sample collection; gastrointestinal biopsy
Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Intestinal Lymphoproliferations
Patients with intestinal lymphoproliferations
Genetic: Blood sample collection; gastrointestinal biopsy
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
Genetic: Blood sample collection; gastrointestinal biopsy
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
Genetic: Blood sample collection; gastrointestinal biopsy
Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...




Primary Outcome Measures :
  1. Intestinal Lymphocytes count [ Time Frame: Baseline ]
    Lymphocytes isolation

  2. DNA sequencing [ Time Frame: Baseline ]
    Targeted Next Generation sequencing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients planned to have blood specimens and possible upper and/or lower digestive endoscopy.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • under guardianship
  • not able to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280510


Contacts
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Contact: Georgia MALAMUT, MD, PhD 33 1 58 41 41 76 georgia.malamut@aphp.fr
Contact: Nadine CERF-BENSUSSAN, MD, PhD 33 1 42 75 42 88 nadine.cerf-bensussan@inserm.fr

Locations
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France
Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Contact: Yoram Bouhnik, MD, PhD       yoram.bouhnik@aphp.fr   
Principal Investigator: Yoram Bouhnik, MD, PhD         
Sub-Investigator: Xavier Treton, MD, PhD         
Hôpital Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Iradj Sobhani, MD, PhD       iradj.sobhani@aphp.fr   
Principal Investigator: Iradj Sobhani, MD, PhD         
Sub-Investigator: Aurélien Amiot, MD, PhD         
Hôpital Bicêtre Not yet recruiting
Le Kremlin Bicêtre, France, 94270
Contact: Franck Carbonnel, MD, PhD       franck.carbonnel@aphp.fr   
Principal Investigator: Franck Carbonnel, MD, PhD         
Hôpital Saint Louis Not yet recruiting
Paris, France, 75010
Contact: Matthieu ALLEZ, MD, PhD       matthieu.allez@aphp.fr   
Principal Investigator: Matthieu Allez, MD, PhD         
Hôpital Saint Antoine Not yet recruiting
Paris, France, 75012
Contact: Laurent Beaugerie, MD, PhD         
Principal Investigator: Laurent Beaugerie, MD, PhD         
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Georgia Malamut, MD, PhD       georgia.malamut@aphp.fr   
Principal Investigator: Georgia MALAMUT, MD, PhD         
Principal Investigator: Stanislas CHAUSSADE, MD, PhD         
Sub-Investigator: Vered ABITBOL, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Imagine Institute
Investigators
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Principal Investigator: Georgia MALAMUT, MD, PhD APHP, Université de Paris (Université Paris Descartes)
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04280510    
Other Study ID Numbers: C19-07
2019-A01594-53 ( Registry Identifier: ID-RCB )
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Celiac Disease
Autoimmune enteropathy
Primary immunodeficiency
Intestinal lymphoma
Liver autoimmune diseases
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Celiac Disease
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Malabsorption Syndromes
Metabolic Diseases