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

NCT02707354 | Completed

• 1 other identifier: RC15_0327
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease

Keywords

GVHD; confocal endomicroscopy

Outcome Measures

Primary Outcomes (1)

• E-mage Score

  The primary endpoint is the evaluation of E-mage score as a new way to detect the early occurrence of GVH amongst patient undergoing Allo-HSCT, considering its sensibility an sensitivity. The E-mage score will be constructed after an expert committee to define semiquantitative or quantitative criteria allowing the classification of pCLE lesions from no GVH to certain GVH. Those criteria will be set regarding the results of the pilot study. The pCLE images will be interpreted by two endoscopists used to pCLE images and blinded from macroscopic observations. Correlation between the E-mage score calculated for each patient and the gold standard histology will be evaluated and sensibility and specificity of the Emage score will be calculated.

  Once for each patient between day 21 and day 28 after graft

Secondary Outcomes (2)

• new early paraclinical markers of GVH and correlation with the occurrence of GVHD

  up to 3 month after graft

• GVHD physiopathology

  within one year

Study Arms (1)

Probe based confocal laser endomicroscopy (Cellvizio)

EXPERIMENTAL

intra-veinous injection of 5 mL of 10% fluorescein diluted in 50 cc of saline serum. The images obtained during the examination will be recorded via the endomicroscopy console.

Device: Probe based confocal laser endomicroscopy (Cellvizio)

Interventions

Probe based confocal laser endomicroscopy (Cellvizio) DEVICE

The probe is a miniaturized microscope in the form of a fiber which is inserted through the endoscope and brought into contact with the mucosa. It thus allows for a "live virtual biopsy", that is to say, obtaining real-time microscopic virtual image of the mucosa. It requires an intra-veinous injection of 5 mL of 10% fluorescein diluted in 50 cc of saline serum. The images obtained during the examination will be recorded via the endomicroscopy console so that two endoscopists blinded from the macroscopic and histological findings can review the data.

Probe based confocal laser endomicroscopy (Cellvizio)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at risk for GVHD, i.e. undergoing HSCT for hematologic disorder
• Patient receiving a reduce intensity conditioning
• Aged 18 years or over
• Underlying hematologic disorder in complete remission
• Willing to participate after informed consent signed

You may not qualify if:

• Patient receiving a myeloablative conditioning regimen
• Patients receiving allo-HSCT from an haploidentical donor or an umbilical cord blood
• Patients receiving a second or beyond allo-HSCT
• Patient with the underlying hematologic disorder in relapse
• Patients having developed engraftment syndrome
• Patients receiving corticosteroid upper 0.5 mg/kg/d
• Patients with ongoing uncontrolled medical condition
• Prior history of allergy to fluorescein
• Renal dysfunction
• Suspected or documented bowel obstruction
• Known inflammatory bowel disease
• History of major abdominal intervention
• No contraception
• Breast-feeding or pregnancy

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CORON Emmanuel

Nantes, 44093, France

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Emmanuel Coron, MD-PHD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 14, 2016
• Study Start: June 3, 2016
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)