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NCT02707354: E-mage

Early Detection of Mucosal Abnormalities in Graft-versus-host Disease

Completed NA Last updated 29 August 2019
What this trial tests

NA trial testing Probe based confocal laser endomicroscopy (Cellvizio) in Graft Versus Host Disease in 19 participants. Completed in 20 August 2018.

Timeline
3 June 2016
Primary endpoint
20 August 2018
20 August 2018

Quick facts

Lead sponsorNantes University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment19
Start date3 June 2016
Primary completion20 August 2018
Estimated completion20 August 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastro-intestinal graft versus host disease (GVHD) is a major source of morbidity and mortality amongst allogenic hematopoietic stem cell transplantation (Allo-HSCT). The diagnosis is based on histological findings that involve colonic biopsies with a risk of bleeding, especially in case of thrombocytopenia. Moreover the diagnosis is frequently made at a clinical stage of the disease, after the appearance of gastro-intestinal symptoms. Endo-microscopy is a novel endoscopic technique that allow "optical biopsies" during a conventional endoscopy and has proved its efficiency in several indications. In a pilot study the investigators showed that it had good sensibility and sensitivity compared to histology as gold standard. Therefore this study aim to identify endo-microscopic criteria allowing the early diagnosis of GHVD before its clinical manifestations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Early remodeling of the colonic mucosa after allogeneic hematopoietic stem cells transplantation: An open-label controlled pilot study on 19 patients.
    Coron E, Esnaud E, Chevallier P, Bessard A, et al · · 2021 · cited 3× · PMID 34431618 · DOI 10.1002/ueg2.12128

Verify or expand the search:

Other recruiting trials for Graft Versus Host Disease

Currently open trials in the same condition.

Other Nantes University Hospital trials

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