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

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Graft Vs Host Disease; Hematopoietic Stem Cells

Treatments: Other: Transcriptomic analysis of GVHD biopsies

Study type: Observational

Funder types: Other

Identifiers

NCT03136757

PI2016_843_0016

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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