Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.

The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).

However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.

The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.

No transcriptomic analysis has ever been performed on human tissues with GVHD.

Study Overview

• Status: Unknown
• Conditions: Graft Vs Host Disease; Hematopoietic Stem Cells
• Intervention / Treatment: Other: Transcriptomic analysis of GVHD biopsies

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recovery of fixed and paraffin-embedded biopsy fragments previously performed during the diagnosis of GVHD, not used for routine histological analysis because in excess, and stored in the pathology laboratory

Description

Inclusion Criteria:

• Person aged ≥ 18 years
• Patients who have received an HSC allograft since June 2012
• Having presented a suspicion of cutaneous or digestive GVHD before J100 post-allograft
• Of which the diagnosis was retained by the combination of clinical and histological criteria
• Or whose diagnosis has been reversed by histological analysis, for the reactive / inflammatory biopsies that serve as control
• The diagnosis of which was made between 01/01/2013 and 31/12/2015
• Survived at least 1 month to monitor clinical progress

Exclusion Criteria:

• Whose biopsy specimens were also the sites of a viral reactivation (EBV, CMV, HHV) that could mimic a GVHD
• Having survived less than 1 month after the diagnosis of GVHD

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transcriptomic profile by analysis of the expression of the mRNAs of a determined panel of 800 genes regulating the immune response	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2017
• Primary Completion (Anticipated): October 20, 2017
• Study Completion (Anticipated): October 20, 2017

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: PI2016_843_0016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No